Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain. (NCT NCT00261495)
NCT ID: NCT00261495
Last Updated: 2014-06-03
Results Overview
Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
COMPLETED
PHASE3
504 participants
baseline and week 24
2014-06-03
Participant Flow
Study conducted in 11 countries (Czech Republic, Denmark, France, Germany, Italy, Norway, Poland, Slovakia, Slovenia, Sweden, and Switzerland). 63 study centres randomized subjects and 1 centre screened 1 subject but did not randomize. Recruitment period: 15 March 2006 (first patient in) to 31 March 2007 (last patient in).
Participant milestones
| Measure |
OROS Hydromorphone HCl
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Titration Phase (Weeks 0 to 4)
STARTED
|
254
|
250
|
|
Titration Phase (Weeks 0 to 4)
COMPLETED
|
206
|
185
|
|
Titration Phase (Weeks 0 to 4)
NOT COMPLETED
|
48
|
65
|
|
Maintenance Phase (Weeks 4 to 24)
STARTED
|
206
|
185
|
|
Maintenance Phase (Weeks 4 to 24)
COMPLETED
|
140
|
137
|
|
Maintenance Phase (Weeks 4 to 24)
NOT COMPLETED
|
66
|
48
|
|
Extension Phase (Weeks 24 to 52)
STARTED
|
60
|
52
|
|
Extension Phase (Weeks 24 to 52)
COMPLETED
|
50
|
47
|
|
Extension Phase (Weeks 24 to 52)
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
OROS Hydromorphone HCl
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Titration Phase (Weeks 0 to 4)
Adverse Event
|
28
|
36
|
|
Titration Phase (Weeks 0 to 4)
Withdrawal by Subject
|
6
|
11
|
|
Titration Phase (Weeks 0 to 4)
Lack of Efficacy
|
8
|
8
|
|
Titration Phase (Weeks 0 to 4)
Physician Decision
|
3
|
1
|
|
Titration Phase (Weeks 0 to 4)
Non-compliance
|
2
|
5
|
|
Titration Phase (Weeks 0 to 4)
Protocol Violation
|
1
|
4
|
|
Maintenance Phase (Weeks 4 to 24)
Adverse Event
|
29
|
20
|
|
Maintenance Phase (Weeks 4 to 24)
Lack of Efficacy
|
14
|
10
|
|
Maintenance Phase (Weeks 4 to 24)
Withdrawal by Subject
|
6
|
5
|
|
Maintenance Phase (Weeks 4 to 24)
Non-compliance
|
1
|
5
|
|
Maintenance Phase (Weeks 4 to 24)
Protocol Violation
|
5
|
2
|
|
Maintenance Phase (Weeks 4 to 24)
Other
|
6
|
5
|
|
Maintenance Phase (Weeks 4 to 24)
Physician Decision
|
1
|
1
|
|
Maintenance Phase (Weeks 4 to 24)
Treatment completed, no follow-up
|
2
|
0
|
|
Maintenance Phase (Weeks 4 to 24)
Lost to Follow-up
|
2
|
0
|
|
Extension Phase (Weeks 24 to 52)
Other
|
4
|
2
|
|
Extension Phase (Weeks 24 to 52)
Adverse Event
|
4
|
1
|
|
Extension Phase (Weeks 24 to 52)
Lack of Efficacy
|
0
|
1
|
|
Extension Phase (Weeks 24 to 52)
Withdrawal by Subject
|
0
|
1
|
|
Extension Phase (Weeks 24 to 52)
Non-compliance
|
1
|
0
|
|
Extension Phase (Weeks 24 to 52)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Baseline characteristics by cohort
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 12.82 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
34 participants
n=5 Participants
|
18 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
France
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
83 participants
n=5 Participants
|
80 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
28 participants
n=5 Participants
|
34 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
14 participants
n=5 Participants
|
19 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 24Population: PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)
Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=115 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=108 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)
|
-2.8 Units on a scale
Standard Deviation 2.04
|
-3.2 Units on a scale
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=233 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=223 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)
|
-2.1 Units on a scale
Standard Deviation 2.43
|
-2.1 Units on a scale
Standard Deviation 2.41
|
PRIMARY outcome
Timeframe: week 24Population: PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)
If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=115 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=108 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)
|
18.9 mg per day
Standard Deviation 9.44
|
48.3 mg per day
Standard Deviation 22.4
|
PRIMARY outcome
Timeframe: week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)
|
18.4 mg per day
Standard Deviation 9.92
|
43.8 mg per day
Standard Deviation 23.12
|
PRIMARY outcome
Timeframe: week 4 to week 24Population: PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)
Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=115 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=108 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Equi-analgesic Dose at Steady-state (PP Population)
|
18.95 mg per day
Standard Deviation 9.223
|
47.82 mg per day
Standard Deviation 21.663
|
PRIMARY outcome
Timeframe: week 4 to week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Equi-analgesic Dose at Steady State (ITT Population)
|
19.50 mg per day
Standard Deviation 9.584
|
48.41 mg per day
Standard Deviation 21.835
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)
|
-1.9 Units on a scale
Standard Deviation 2.20
|
-1.9 Units on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality at Week 24
|
-8.8 Units on a scale
Standard Deviation 18.44
|
-6.2 Units on a scale
Standard Deviation 18.33
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline to week 24 in subject diary evening mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24
|
-2.2 Units on a scale
Standard Deviation 2.08
|
-2.0 Units on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline to week 24 in subject diary morning mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24
|
-2.0 Units on a scale
Standard Deviation 2.33
|
-2.0 Units on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: week 4 and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of subjects with dose increase in study medication.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=203 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=182 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Subjects With Dose Escalation
Yes
|
27 Subjects
|
34 Subjects
|
|
Number of Subjects With Dose Escalation
No
|
176 Subjects
|
148 Subjects
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain right now" (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Severity Score "Pain Right Now" (BPI Item 6) at Week 4
|
-2.2 Units on a scale
Standard Deviation 2.34
|
-2.6 Units on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity Score "Pain at Its Least" (BPI Item 4) at Week 4
|
-1.3 Units on a scale
Standard Deviation 2.03
|
-1.8 Units on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity "Pain at Its Worst" (BPI Item 3) at Week 4
|
-1.8 Units on a scale
Standard Deviation 2.14
|
-2.1 Units on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 4
|
-1.9 Units on a scale
Standard Deviation 1.89
|
-2.1 Units on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4
|
13.8 Units on a scale
Standard Deviation 25.15
|
15.2 Units on a scale
Standard Deviation 26.27
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4
|
-1.7 Units on a scale
Standard Deviation 1.76
|
-2.0 Units on a scale
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity "Pain at Its Least" (BPI Item 4) at Week 24
|
-1.3 Units on a scale
Standard Deviation 2.23
|
-1.4 Units on a scale
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 24
|
-1.8 Units on a scale
Standard Deviation 2.07
|
-1.7 Units on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24
|
8.6 Units on a scale
Standard Deviation 29.32
|
11.5 Units on a scale
Standard Deviation 28.95
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24
|
-1.6 Units on a scale
Standard Deviation 1.91
|
-1.7 Units on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Interference Score "Interfered With General Activity" (BPI Item 9a) at Week 4
|
-1.6 Units on a scale
Standard Deviation 2.14
|
-1.9 Units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 4
|
-1.7 Units on a scale
Standard Deviation 2.32
|
-1.9 Units on a scale
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 4
|
-1.2 Units on a scale
Standard Deviation 2.63
|
-1.5 Units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 4
|
-1.4 Units on a scale
Standard Deviation 2.40
|
-2.0 Units on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 4
|
-1.1 Units on a scale
Standard Deviation 2.56
|
-1.4 Units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 4
|
-2.1 Units on a scale
Standard Deviation 2.34
|
-2.3 Units on a scale
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 4
|
-1.6 Units on a scale
Standard Deviation 2.62
|
-1.9 Units on a scale
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With General Activity" (BPI Item 9a) at Week 24
|
-1.6 Units on a scale
Standard Deviation 2.42
|
-1.6 Units on a scale
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 24
|
-1.4 Units on a scale
Standard Deviation 2.85
|
-1.3 Units on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 24
|
-1.1 Units on a scale
Standard Deviation 2.75
|
-1.2 Units on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 24
|
-1.3 Units on a scale
Standard Deviation 2.63
|
-1.4 Units on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 24
|
-0.7 Units on a scale
Standard Deviation 2.92
|
-0.9 Units on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 24
|
-1.4 Units on a scale
Standard Deviation 2.76
|
-1.5 Units on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 24
|
-1.2 Units on a scale
Standard Deviation 2.91
|
-1.3 Units on a scale
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: baseline and week 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain severity, BPI items 3 to 6
|
-2.4 Units on a scale
Standard Deviation 1.67
|
-2.4 Units on a scale
Standard Deviation 2.13
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain relief, BPI item 8
|
17.7 Units on a scale
Standard Deviation 26.36
|
23.6 Units on a scale
Standard Deviation 25.46
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain right now, BPI item 6
|
-2.9 Units on a scale
Standard Deviation 2.07
|
-2.8 Units on a scale
Standard Deviation 2.16
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain at its worst, BPI item 3
|
-2.8 Units on a scale
Standard Deviation 2.07
|
-2.4 Units on a scale
Standard Deviation 2.29
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain at its least, BPI item 4
|
-1.9 Units on a scale
Standard Deviation 2.14
|
-2.3 Units on a scale
Standard Deviation 2.59
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Average pain, BPI item 5
|
-2.6 Units on a scale
Standard Deviation 1.78
|
-2.6 Units on a scale
Standard Deviation 2.21
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain interfered general activity, BPI item 9a
|
-2.5 Units on a scale
Standard Deviation 2.28
|
-2.6 Units on a scale
Standard Deviation 2.40
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain interfered mood, BPI item 9b
|
-2.3 Units on a scale
Standard Deviation 2.42
|
-2.7 Units on a scale
Standard Deviation 3.12
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain interfered walking ability, BPI item 9c
|
-2.3 Units on a scale
Standard Deviation 2.10
|
-2.5 Units on a scale
Standard Deviation 2.89
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain interfered normal work, BPI item 9d
|
-2.9 Units on a scale
Standard Deviation 2.64
|
-3.2 Units on a scale
Standard Deviation 2.63
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
BPI pain interfered sleep, BPI item 9f
|
-2.4 Units on a scale
Standard Deviation 2.61
|
-3.0 Units on a scale
Standard Deviation 3.02
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
BPI pain interfered enjoyment of life, BPI item 9g
|
-2.4 Units on a scale
Standard Deviation 2.63
|
-2.6 Units on a scale
Standard Deviation 3.32
|
|
Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Pain interfered relation other people, BPI item 9e
|
-1.6 Units on a scale
Standard Deviation 2.56
|
-1.9 Units on a scale
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality (MOS Index I) at Week 4
|
-10.6 Units on a scale
Standard Deviation 17.61
|
-8.7 Units on a scale
Standard Deviation 18.83
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality (MOS Index II) at Week 4
|
-10.5 Units on a scale
Standard Deviation 16.40
|
-9.0 Units on a scale
Standard Deviation 17.80
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality (MOS Index II) at Week 24
|
-8.9 Units on a scale
Standard Deviation 17.28
|
-6.5 Units on a scale
Standard Deviation 16.73
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24
|
-13.1 Units on a scale
Standard Deviation 22.77
|
-11.7 Units on a scale
Standard Deviation 22.95
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality, Snoring at Week 24
|
-1.0 Units on a scale
Standard Deviation 22.04
|
-4.1 Units on a scale
Standard Deviation 21.93
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24
|
-5.3 Units on a scale
Standard Deviation 28.44
|
-0.1 Units on a scale
Standard Deviation 24.27
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24
|
9.1 Units on a scale
Standard Deviation 28.10
|
7.3 Units on a scale
Standard Deviation 26.63
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24
|
-1.6 Units on a scale
Standard Deviation 21.70
|
3.0 Units on a scale
Standard Deviation 20.91
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality, Sleep Quantity at Week 24
|
0.4 Units on a scale
Standard Deviation 1.86
|
0.5 Units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=249 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=242 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Subjects Indicating That They Had Optimal Sleep at Week 24
Yes
|
83 Subjects
|
71 Subjects
|
|
Number of Subjects Indicating That They Had Optimal Sleep at Week 24
No
|
166 Subjects
|
171 Subjects
|
SECONDARY outcome
Timeframe: baseline and week 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Sleep Quality at Week 52
MOS sleep disturbance
|
-17.6 Units on a scale
Standard Deviation 22.44
|
-20.1 Units on a scale
Standard Deviation 23.17
|
|
Change From Baseline in Sleep Quality at Week 52
MOS snoring
|
-2.5 Units on a scale
Standard Deviation 23.01
|
-4.7 Units on a scale
Standard Deviation 23.86
|
|
Change From Baseline in Sleep Quality at Week 52
MOS sleep shortness of breath or headache
|
-8.4 Units on a scale
Standard Deviation 19.89
|
-7.8 Units on a scale
Standard Deviation 21.94
|
|
Change From Baseline in Sleep Quality at Week 52
MOS sleep adequacy
|
12.3 Units on a scale
Standard Deviation 27.06
|
11.9 Units on a scale
Standard Deviation 30.74
|
|
Change From Baseline in Sleep Quality at Week 52
MOS sleep somnolence
|
-6.5 Units on a scale
Standard Deviation 20.49
|
1.8 Units on a scale
Standard Deviation 21.54
|
|
Change From Baseline in Sleep Quality at Week 52
MOS sleep quantity
|
0.5 Units on a scale
Standard Deviation 2.27
|
0.5 Units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: week 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=55 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=49 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Subjects Indicating Optimal Sleep at Week 52
Yes
|
27 Subjects
|
19 Subjects
|
|
Number of Subjects Indicating Optimal Sleep at Week 52
No
|
28 Subjects
|
30 Subjects
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Morning worst pain
|
-1.9 Units on a scale
Standard Deviation 2.38
|
-2.1 Units on a scale
Standard Deviation 2.34
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Morning least pain
|
-1.5 Units on a scale
Standard Deviation 2.44
|
-1.2 Units on a scale
Standard Deviation 2.44
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Morning average pain
|
-1.7 Units on a scale
Standard Deviation 2.20
|
-1.8 Units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
All day worst pain
|
-2.1 Units on a scale
Standard Deviation 2.11
|
-2.1 Units on a scale
Standard Deviation 2.09
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
All day least pain
|
-1.5 Units on a scale
Standard Deviation 2.21
|
-1.3 Units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Evening worst pain
|
-2.2 Units on a scale
Standard Deviation 2.32
|
-2.1 Units on a scale
Standard Deviation 2.31
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Evening least pain
|
-1.6 Units on a scale
Standard Deviation 2.28
|
-1.4 Units on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Evening average pain
|
-2.0 Units on a scale
Standard Deviation 2.12
|
-1.8 Units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
All day average pain
|
-1.8 Units on a scale
Standard Deviation 2.00
|
-1.8 Units on a scale
Standard Deviation 2.08
|
|
Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
All day pain right now
|
-2.1 Units on a scale
Standard Deviation 2.05
|
-2.0 Units on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: baseline and weeks 4, 8, 12, 16, 20, and 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in subject diary mean pain score "pain at its worst" from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score "pain at its worst".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Baseline
|
0.7 Units on a scale
Standard Deviation 1.93
|
0.4 Units on a scale
Standard Deviation 1.88
|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Week 4
|
0.5 Units on a scale
Standard Deviation 1.30
|
0.4 Units on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Week 8
|
0.4 Units on a scale
Standard Deviation 1.23
|
0.4 Units on a scale
Standard Deviation 1.42
|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Week 12
|
0.3 Units on a scale
Standard Deviation 1.23
|
0.3 Units on a scale
Standard Deviation 1.26
|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Week 16
|
0.2 Units on a scale
Standard Deviation 1.08
|
0.2 Units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Week 20
|
0.3 Units on a scale
Standard Deviation 1.13
|
0.2 Units on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Week 24
|
0.3 Units on a scale
Standard Deviation 1.23
|
0.3 Units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
The number of subjects with dose increase in study medication was assessed at week 4.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Subjects With Dose Escalation at Week 4 (ITT Population)
Yes
|
175 Subjects
|
166 Subjects
|
|
Number of Subjects With Dose Escalation at Week 4 (ITT Population)
No
|
79 Subjects
|
84 Subjects
|
SECONDARY outcome
Timeframe: week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
The number of subjects with dose increase in study medication was assessed at week 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=203 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=182 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Subjects With Dose Escalation at Week 24 (ITT Population)
Yes
|
146 Subjects
|
145 Subjects
|
|
Number of Subjects With Dose Escalation at Week 24 (ITT Population)
No
|
57 Subjects
|
37 Subjects
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in Quality of Life (QoL) "Bodily Pain" at Week 4
|
13.7 Units on a scale
Standard Deviation 18.10
|
16.7 Units on a scale
Standard Deviation 18.43
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "General Health Perceptions" at Week 4
|
3.9 Units on a scale
Standard Deviation 14.43
|
5.0 Units on a scale
Standard Deviation 16.97
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Health Transition" at Week 4
|
-0.4 Units on a scale
Standard Deviation 1.08
|
-0.5 Units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Mental Health" at Week 4
|
6.2 Units on a scale
Standard Deviation 15.76
|
6.6 Units on a scale
Standard Deviation 17.17
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Physical Functioning" at Week 4
|
8.7 Units on a scale
Standard Deviation 17.05
|
5.4 Units on a scale
Standard Deviation 16.80
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional".
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Role Emotional" at Week 4
|
9.9 Units on a scale
Standard Deviation 43.25
|
4.7 Units on a scale
Standard Deviation 48.03
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Role Physical" at Week 4
|
13.2 Units on a scale
Standard Deviation 36.84
|
16.9 Units on a scale
Standard Deviation 36.08
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Social Functioning" at Week 4
|
10.5 Units on a scale
Standard Deviation 25.33
|
12.9 Units on a scale
Standard Deviation 26.39
|
SECONDARY outcome
Timeframe: baseline and week 4Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Vitality" at Week 4
|
6.4 Units on a scale
Standard Deviation 16.92
|
9.2 Units on a scale
Standard Deviation 17.08
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Bodily Pain" at Week 24
|
10.6 Units on a scale
Standard Deviation 21.04
|
11.9 Units on a scale
Standard Deviation 19.83
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "General Health Perceptions" at Week 24
|
2.1 Units on a scale
Standard Deviation 17.04
|
2.2 Units on a scale
Standard Deviation 16.61
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Health Transition" at Week 24
|
-0.2 Units on a scale
Standard Deviation 1.03
|
-0.1 Units on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Mental Health" at Week 24
|
2.6 Units on a scale
Standard Deviation 19.30
|
2.6 Units on a scale
Standard Deviation 18.79
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Physical Functioning" at Week 24
|
7.7 Units on a scale
Standard Deviation 19.09
|
4.4 Units on a scale
Standard Deviation 15.33
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional."
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Role Emotional" at Week 24
|
0.40 Units on a scale
Standard Deviation 47.71
|
-1.5 Units on a scale
Standard Deviation 47.22
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Role Physical" at Week 24
|
8.8 Units on a scale
Standard Deviation 37.80
|
9.9 Units on a scale
Standard Deviation 34.11
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Social Functioning" at Week 24
|
6.6 Units on a scale
Standard Deviation 27.81
|
5.0 Units on a scale
Standard Deviation 26.85
|
SECONDARY outcome
Timeframe: baseline and week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL "Vitality" at Week 24
|
4.3 Units on a scale
Standard Deviation 19.73
|
5.6 Units on a scale
Standard Deviation 17.93
|
SECONDARY outcome
Timeframe: baseline and week 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change From Baseline in QoL at Week 52
SF-36 bodily pain index
|
23.1 Units on a scale
Standard Deviation 22.07
|
19.6 Units on a scale
Standard Deviation 22.67
|
|
Change From Baseline in QoL at Week 52
SF-36 general health perceptions
|
9.6 Units on a scale
Standard Deviation 17.86
|
5.5 Units on a scale
Standard Deviation 18.97
|
|
Change From Baseline in QoL at Week 52
SF-36 health transition
|
-0.3 Units on a scale
Standard Deviation 0.90
|
-0.1 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in QoL at Week 52
SF-36 mental health
|
11.7 Units on a scale
Standard Deviation 17.21
|
6.9 Units on a scale
Standard Deviation 26.03
|
|
Change From Baseline in QoL at Week 52
SF-36 physical functioning
|
11.4 Units on a scale
Standard Deviation 20.10
|
9.2 Units on a scale
Standard Deviation 20.12
|
|
Change From Baseline in QoL at Week 52
SF-36 role emotional
|
22.1 Units on a scale
Standard Deviation 48.86
|
7.3 Units on a scale
Standard Deviation 56.86
|
|
Change From Baseline in QoL at Week 52
SF-36 role physical
|
17.0 Units on a scale
Standard Deviation 38.02
|
15.0 Units on a scale
Standard Deviation 33.50
|
|
Change From Baseline in QoL at Week 52
SF-36 social functioning
|
15.4 Units on a scale
Standard Deviation 23.11
|
12.8 Units on a scale
Standard Deviation 28.29
|
|
Change From Baseline in QoL at Week 52
SF-36 vitality
|
11.5 Units on a scale
Standard Deviation 17.39
|
11.9 Units on a scale
Standard Deviation 21.40
|
SECONDARY outcome
Timeframe: weeks 4, 24, and 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Clinical Global Assessment of Efficacy
Visit 5, week 4: very good
|
49 Subjects
|
27 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 5, week 4: good
|
92 Subjects
|
92 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 5, week 4: moderate
|
51 Subjects
|
50 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 5, week 4: poor
|
12 Subjects
|
9 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 5, week 4: very poor
|
0 Subjects
|
3 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 8, week 24: very good
|
48 Subjects
|
31 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 8, week 24: good
|
91 Subjects
|
103 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 8, week 24: moderate
|
50 Subjects
|
41 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 10, week 52: moderate
|
5 Subjects
|
6 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 10, week 52: poor
|
0 Subjects
|
1 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 10, week 52: very poor
|
0 Subjects
|
0 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 8, week 24: poor
|
44 Subjects
|
50 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 8, week 24: very poor
|
16 Subjects
|
10 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 10, week 52: very good
|
18 Subjects
|
11 Subjects
|
|
Clinical Global Assessment of Efficacy
Visit 10, week 52: good
|
37 Subjects
|
34 Subjects
|
SECONDARY outcome
Timeframe: weeks 4, 24, and 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change in Dose of Study Treatment
0 mg (week 4)
|
79 Subjects
|
84 Subjects
|
|
Change in Dose of Study Treatment
+8 mg (week 4)
|
102 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
+20 mg (week 4)
|
0 Subjects
|
108 Subjects
|
|
Change in Dose of Study Treatment
+24 mg (week 4)
|
73 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
+60 mg (week 4)
|
0 Subjects
|
58 Subjects
|
|
Change in Dose of Study Treatment
-60 mg (week 24)
|
0 Subjects
|
2 Subjects
|
|
Change in Dose of Study Treatment
-40 mg (week 24)
|
0 Subjects
|
8 Subjects
|
|
Change in Dose of Study Treatment
-24 mg (week 24)
|
1 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
-20 mg (week 24)
|
0 Subjects
|
6 Subjects
|
|
Change in Dose of Study Treatment
-16 mg (week 24)
|
4 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
-8 mg (week 24)
|
11 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
0 mg (week 24)
|
172 Subjects
|
144 Subjects
|
|
Change in Dose of Study Treatment
+8 mg (week 24)
|
6 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
+16 mg (week 24)
|
9 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
+20 mg (week 24)
|
0 Subjects
|
8 Subjects
|
|
Change in Dose of Study Treatment
+40 mg (week 24)
|
0 Subjects
|
14 Subjects
|
|
Change in Dose of Study Treatment
-16 mg (week 52)
|
3 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
-8 mg (week 52)
|
1 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment
0 mg (week 52)
|
56 Subjects
|
50 Subjects
|
|
Change in Dose of Study Treatment
+40 mg (week 52)
|
0 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: weeks 4 and 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study at least 4 weeks) +20 mg
|
0 Subjects
|
94 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study at least 4 weeks) +24 mg
|
65 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study at least 4 weeks) +60 mg
|
0 Subjects
|
54 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study <4 weeks) 0 mg
|
29 Subjects
|
43 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study <4 weeks) +8 mg
|
10 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study <4 weeks) +20 mg
|
0 Subjects
|
14 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study <4 weeks) +24 mg
|
8 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study <4 weeks) +60 mg
|
0 Subjects
|
4 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study at least 4 weeks) 0 mg
|
58 Subjects
|
40 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study at least 4 weeks ) +4 mg
|
0 Subjects
|
1 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study at least 4 weeks ) +8 mg
|
76 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study at least 4 weeks) +20 mg
|
0 Subjects
|
87 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study at least 4 weeks ) +24 mg
|
73 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study <4 weeks) +20 mg
|
0 Subjects
|
14 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study <4 weeks) +24 mg
|
8 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study <4 weeks) +60 mg
|
0 Subjects
|
4 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study at least 4 weeks) 0 mg
|
50 Subjects
|
41 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Titration phase (on study at least 4 weeks) +8 mg
|
92 Subjects
|
0 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study at least 4 weeks) +60 mg
|
0 Subjects
|
61 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study <4 weeks) 0 mg
|
29 Subjects
|
43 Subjects
|
|
Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
Week 24 (on study <4 weeks) +8 mg
|
10 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: baseline to week 24 (core); week 24 to week 52 (extension)Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Drop-outs
Consent withdrawn (core)
|
12 Subjects
|
16 Subjects
|
|
Number of Drop-outs
Consent withdrawn (extension)
|
0 Subjects
|
1 Subjects
|
|
Number of Drop-outs
Inadequate pain relief (core)
|
22 Subjects
|
18 Subjects
|
|
Number of Drop-outs
Inadequate pain relief (extension)
|
0 Subjects
|
1 Subjects
|
|
Number of Drop-outs
Investigator withdrew patient (core)
|
4 Subjects
|
2 Subjects
|
|
Number of Drop-outs
Investigator withdrew patient (extension)
|
0 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Lost to follow up (core)
|
2 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Lost to follow up (extension)
|
1 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Other (core)
|
6 Subjects
|
5 Subjects
|
|
Number of Drop-outs
Other (extension)
|
4 Subjects
|
2 Subjects
|
|
Number of Drop-outs
Protocol violation (core)
|
6 Subjects
|
6 Subjects
|
|
Number of Drop-outs
Protocol violation (extension)
|
0 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Treatment completed no follow up visit (core)
|
2 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Adverse events (core)
|
57 Subjects
|
56 Subjects
|
|
Number of Drop-outs
Adverse events (extension)
|
4 Subjects
|
1 Subjects
|
|
Number of Drop-outs
Non compliance (core)
|
3 Subjects
|
10 Subjects
|
|
Number of Drop-outs
Non compliance (extension)
|
1 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Treatment completed no follow up visit (extension)
|
0 Subjects
|
0 Subjects
|
|
Number of Drop-outs
Inefficacy at maximal dosage (core)
|
17 Subjects
|
12 Subjects
|
SECONDARY outcome
Timeframe: week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Number of Days With add-on Pain Medication
|
68.2 Days
Standard Deviation 59.6
|
66.1 Days
Standard Deviation 61.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Amount of add-on Pain Medication
|
80004.8 mg
Standard Deviation 97004.53
|
76191.9 mg
Standard Deviation 96925.72
|
SECONDARY outcome
Timeframe: weeks 4, 24, and 52Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Mode and Convenience of Drug Intake.
Very convenient, week 4
|
57 Subjects
0.86
|
36 Subjects
0.77
|
|
Mode and Convenience of Drug Intake.
Convenient, week 4
|
97 Subjects
0.96
|
94 Subjects
1.01
|
|
Mode and Convenience of Drug Intake.
Neither convenient or inconvenient, week 4
|
30 Subjects
0.61
|
30 Subjects
0.61
|
|
Mode and Convenience of Drug Intake.
Inconvenient, week 4
|
7 Subjects
|
6 Subjects
|
|
Mode and Convenience of Drug Intake.
Neither convenient or inconvenient, week 24
|
31 Subjects
|
33 Subjects
|
|
Mode and Convenience of Drug Intake.
Inconvenient, week 24
|
8 Subjects
|
11 Subjects
|
|
Mode and Convenience of Drug Intake.
Very inconvenient, week 24
|
7 Subjects
|
8 Subjects
|
|
Mode and Convenience of Drug Intake.
Very convenient, week 52
|
21 Subjects
|
11 Subjects
|
|
Mode and Convenience of Drug Intake.
Convenient, week 52
|
10 Subjects
|
15 Subjects
|
|
Mode and Convenience of Drug Intake.
Neither convenient or inconvenient, week 52
|
2 Subjects
|
2 Subjects
|
|
Mode and Convenience of Drug Intake.
Inconvenient, week 52
|
0 Subjects
|
0 Subjects
|
|
Mode and Convenience of Drug Intake.
Very inconvenient, week 52
|
0 Subjects
|
0 Subjects
|
|
Mode and Convenience of Drug Intake.
Very inconvenient, week 4
|
3 Subjects
|
1 Subjects
|
|
Mode and Convenience of Drug Intake.
Very convenient, week 24
|
63 Subjects
|
53 Subjects
|
|
Mode and Convenience of Drug Intake.
Convenient, week 24
|
96 Subjects
|
90 Subjects
|
SECONDARY outcome
Timeframe: week 24Population: ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.
Outcome measures
| Measure |
OROS Hydromorphone HCl
n=254 Participants
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 Participants
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Resource Utilization of Pain Management
|
2.1 Additional visits
Standard Deviation 2.21
|
1.9 Additional visits
Standard Deviation 2.29
|
Adverse Events
OROS Hydromorphone HCl
Oxycodone
Serious adverse events
| Measure |
OROS Hydromorphone HCl
n=254 participants at risk
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 participants at risk
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
2/254 • Number of events 2
|
0.40%
1/250 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
2/254 • Number of events 2
|
0.80%
2/250 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Rectocele
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
General disorders
Asthenia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
General disorders
Condition aggravated
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
General disorders
Drug withdrawal syndrome
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
General disorders
Fatigue
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
General disorders
Withdrawal syndrome
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Infections and infestations
Paronychia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Investigations
Biopsy liver
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
1/254 • Number of events 1
|
0.80%
2/250 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
Parkinson's disease
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Nervous system disorders
Sedation
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Nervous system disorders
Somnolence
|
0.39%
1/254 • Number of events 1
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Reproductive system and breast disorders
Dyspnoea
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Pain management
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
|
Surgical and medical procedures
Prosthesis implantation
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Spinal operation
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.39%
1/254 • Number of events 1
|
0.00%
0/250
|
|
Vascular disorders
Hypotension
|
0.00%
0/254
|
0.40%
1/250 • Number of events 1
|
Other adverse events
| Measure |
OROS Hydromorphone HCl
n=254 participants at risk
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
|
Oxycodone
n=250 participants at risk
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.5%
14/254 • Number of events 14
|
6.4%
16/250 • Number of events 17
|
|
Gastrointestinal disorders
Constipation
|
28.7%
73/254 • Number of events 92
|
26.0%
65/250 • Number of events 76
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
33/254 • Number of events 45
|
5.6%
14/250 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
26.8%
68/254 • Number of events 82
|
31.2%
78/250 • Number of events 92
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
32/254 • Number of events 38
|
14.4%
36/250 • Number of events 43
|
|
General disorders
Fatigue
|
13.8%
35/254 • Number of events 37
|
12.4%
31/250 • Number of events 33
|
|
Metabolism and nutrition disorders
Anorexia
|
5.5%
14/254 • Number of events 16
|
5.2%
13/250 • Number of events 13
|
|
Nervous system disorders
Dizziness
|
6.7%
17/254 • Number of events 18
|
10.4%
26/250 • Number of events 30
|
|
Nervous system disorders
Headache
|
8.7%
22/254 • Number of events 26
|
10.0%
25/250 • Number of events 32
|
|
Nervous system disorders
Somnolence
|
3.5%
9/254 • Number of events 10
|
7.2%
18/250 • Number of events 23
|
|
Psychiatric disorders
Insomnia
|
5.1%
13/254 • Number of events 13
|
6.0%
15/250 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.4%
29/254 • Number of events 35
|
8.8%
22/250 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.8%
25/254 • Number of events 27
|
10.4%
26/250 • Number of events 28
|
Additional Information
EMEA Medical Affairs Director Analgesia
Janssen Pharmaceutica NV
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60