Trial Outcomes & Findings for An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer (NCT NCT01006356)
NCT ID: NCT01006356
Last Updated: 2013-08-08
Results Overview
Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
141 participants
Primary outcome timeframe
Day 15
Results posted on
2013-08-08
Participant Flow
Participant milestones
| Measure |
Hydromorphone Hydrochloride Oral Osmotic System
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
141
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Hydromorphone Hydrochloride Oral Osmotic System
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Paticipants did not cooperate
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Choice by participants
|
2
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Other
|
23
|
Baseline Characteristics
An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer
Baseline characteristics by cohort
| Measure |
Hydromorphone HCl OROS
n=106 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Age Continuous
|
57.94 Years
STANDARD_DEVIATION 11.27 • n=93 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.
Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=106 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
|
50.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.
Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=106 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Frequency of Experiencing Breakthrough Pain
Day 1: Incidental Pain
|
1.1 Pain episodes per day
Standard Deviation 1.4
|
|
Frequency of Experiencing Breakthrough Pain
Day 15: Incidental Pain
|
0.8 Pain episodes per day
Standard Deviation 1.1
|
|
Frequency of Experiencing Breakthrough Pain
Day 1: Idiopathic Pain
|
1.8 Pain episodes per day
Standard Deviation 1.6
|
|
Frequency of Experiencing Breakthrough Pain
Day 15: Idiopathic Pain
|
1.2 Pain episodes per day
Standard Deviation 1.3
|
|
Frequency of Experiencing Breakthrough Pain
Day 1: End-of-dose failure
|
1.0 Pain episodes per day
Standard Deviation 1.6
|
|
Frequency of Experiencing Breakthrough Pain
Day 15: End-of-dose failure
|
0.6 Pain episodes per day
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.
K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=106 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
Baseline
|
3.66 Units on a scale
Standard Deviation 1.29
|
|
Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
Change at Day 15
|
0.359 Units on a scale
Standard Deviation 1.191
|
SECONDARY outcome
Timeframe: Day 3 and Day 13Population: The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.
Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=106 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Pain Intensity Score
Day 3 (8 AM) (n=106)
|
3.7 Units on a scale
Standard Deviation 1.8
|
|
Pain Intensity Score
Day 3 (8 PM) (n=106)
|
3.6 Units on a scale
Standard Deviation 1.8
|
|
Pain Intensity Score
Day 13 (8 AM) (n=103)
|
3.3 Units on a scale
Standard Deviation 1.8
|
|
Pain Intensity Score
Day 13 (8 PM) (n=103)
|
3.3 Units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Day 15Population: The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.
Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=104 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Global Assessment of Overall Efficacy of Study Drug by Investigator
Ineffective response
|
4 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Investigator
Average response
|
37 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Investigator
Effective response
|
48 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Investigator
Very effective response
|
12 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Investigator
Highly effective response
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.
Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=104 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Global Assessment of Overall Efficacy of Study Drug by Participant
Ineffective
|
9 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Participant
Average
|
31 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Participant
Effective
|
49 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Participant
Very effective
|
12 Participants
|
|
Global Assessment of Overall Efficacy of Study Drug by Participant
Highly effective
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.
The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=100 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Participant's Preferences Along With Reasons
Hydromorphone OROS:Consistent effect(n=91)
|
33 Participants
|
|
Participant's Preferences Along With Reasons
Oral Opioid: Consistent effect(n=9)
|
1 Participants
|
|
Participant's Preferences Along With Reasons
Hydromorphone OROS: Sleep undisturbed(n=91)
|
3 Participants
|
|
Participant's Preferences Along With Reasons
Hydromorphone OROS:reduced intake frequency(n=91)
|
74 Participants
|
|
Participant's Preferences Along With Reasons
Hydromorphone OROS:reduced intake(n=91)
|
29 Participants
|
|
Participant's Preferences Along With Reasons
Hydromorphone OROS:Other(n=91)
|
2 Participants
|
|
Participant's Preferences Along With Reasons
Oral Opioid: Other(n=9)
|
8 Participants
|
|
Participant's Preferences Along With Reasons
Oral Opioid: No response(n=9)
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.
Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=104 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
greatly improved
|
3 Participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
somewhat improved
|
23 Participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
slightly improved
|
45 Participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
no change
|
30 Participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
slightly aggravated
|
1 Participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
somewhat aggravated
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.
Outcome measures
| Measure |
Hydromorphone HCl OROS
n=106 Participants
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Trouble in strenuous activities (n=106)
|
3.00 Units on a Scale
Standard Deviation 0.79
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Trouble in strenuous activities (n=106)
|
3.07 Units on a Scale
Standard Deviation 0.84
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Trouble in long walk (n=106)
|
2.98 Units on a Scale
Standard Deviation 0.78
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Trouble in long walk (n=106)
|
3.18 Units on a Scale
Standard Deviation 0.79
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Trouble in short walk outside house (n=106)
|
1.98 Units on a Scale
Standard Deviation 0.93
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Trouble in short walk outside house(n=106)
|
2.22 Units on a Scale
Standard Deviation 0.99
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Stay in bed/chair (n=106)
|
2.64 Units on a Scale
Standard Deviation 0.83
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Stay in bed/chair (n=106)
|
2.71 Units on a Scale
Standard Deviation 0.78
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Need help in usual activities (n=106)
|
1.56 Units on a Scale
Standard Deviation 0.84
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Need help in usual activities (n=106)
|
1.72 Units on a Scale
Standard Deviation 0.95
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Felt weak (n=106)
|
2.50 Units on a Scale
Standard Deviation 0.77
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Vomitting (n=106)
|
1.29 Units on a Scale
Standard Deviation 0.53
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Vomitting (n=106)
|
1.24 Units on a Scale
Standard Deviation 0.51
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Constipation (n=106)
|
2.15 Units on a Scale
Standard Deviation 0.99
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Constipation (n=106)
|
2.08 Units on a Scale
Standard Deviation 0.96
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Diarrhea (n=106)
|
1.34 Units on a Scale
Standard Deviation 0.65
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Diarrhea (n=106)
|
1.18 Units on a Scale
Standard Deviation 0.47
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Tired (n=106)
|
2.62 Units on a Scale
Standard Deviation 0.79
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Tired (n=106)
|
2.51 Units on a Scale
Standard Deviation 0.78
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Felt depressed (n=106)
|
1.94 Units on a Scale
Standard Deviation 0.88
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Difficulty in remembering (n=104)
|
2.02 Units on a Scale
Standard Deviation 0.87
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Difficulty in remembering (n=104)
|
1.95 Units on a Scale
Standard Deviation 0.84
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Interference in family life (n=106)
|
2.47 Units on a Scale
Standard Deviation 0.88
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Interference in social life (n=106)
|
2.58 Units on a Scale
Standard Deviation 0.88
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Interference in social life (n=106)
|
2.60 Units on a Scale
Standard Deviation 0.90
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Economical difficulties (n=106)
|
2.58 Units on a Scale
Standard Deviation 0.82
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Economical difficulties (n=106)
|
2.51 Units on a Scale
Standard Deviation 0.81
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Global health status (n=106)
|
3.42 Units on a Scale
Standard Deviation 1.01
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Quality of life (n=106)
|
3.47 Units on a Scale
Standard Deviation 1.04
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Quality of life (n=106)
|
3.44 Units on a Scale
Standard Deviation 1.08
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1:Pain interference - daily activities(n=106)
|
2.69 Units on a Scale
Standard Deviation 0.85
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15:Pain interference - daily activities(n=106)
|
2.60 Units on a Scale
Standard Deviation 0.81
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Difficulty in concentrating (n=106)
|
2.10 Units on a Scale
Standard Deviation 0.84
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Difficulty in concentrating (n=106)
|
2.13 Units on a Scale
Standard Deviation 0.85
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Felt tensed (n=106)
|
1.95 Units on a Scale
Standard Deviation 0.76
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Felt tensed (n=106)
|
2.01 Units on a Scale
Standard Deviation 0.77
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Worried (n=106)
|
2.12 Units on a Scale
Standard Deviation 0.78
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Worried (n=106)
|
2.16 Units on a Scale
Standard Deviation 0.81
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Felt irritated (n=106)
|
2.22 Units on a Scale
Standard Deviation 0.83
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Felt irritated (n=106)
|
2.20 Units on a Scale
Standard Deviation 0.86
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Felt depressed (n=106)
|
2.07 Units on a Scale
Standard Deviation 0.82
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Interference in family life (n=106)
|
2.59 Units on a Scale
Standard Deviation 0.87
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Global health status (n=106)
|
3.42 Units on a Scale
Standard Deviation 1.15
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Limitation in work/other activites (n=106)
|
2.58 Units on a Scale
Standard Deviation 0.81
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Limitation in work/other activites (n=106)
|
2.66 Units on a Scale
Standard Deviation 0.84
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1:Limitation-hobbies/leisure activites(n=106)
|
2.56 Units on a Scale
Standard Deviation 0.85
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15:Limitation-hobbies/leisure activites(n=106)
|
2.61 Units on a Scale
Standard Deviation 0.85
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Short of breath (n=106)
|
2.02 Units on a Scale
Standard Deviation 0.86
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Short of breath (n=106)
|
2.04 Units on a Scale
Standard Deviation 0.87
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Had pain (n=106)
|
2.90 Units on a Scale
Standard Deviation 0.74
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Had pain (n=106)
|
2.66 Units on a Scale
Standard Deviation 0.79
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Needs rest (n=105)
|
2.74 Units on a Scale
Standard Deviation 0.81
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Needs rest (n=105)
|
2.78 Units on a Scale
Standard Deviation 0.75
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Trouble in sleeping (n=106)
|
2.18 Units on a Scale
Standard Deviation 0.90
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Trouble in sleeping (n=106)
|
2.13 Units on a Scale
Standard Deviation 0.87
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Felt weak (n=106)
|
2.52 Units on a Scale
Standard Deviation 0.78
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Apetite loss (n=106)
|
2.27 Units on a Scale
Standard Deviation 0.91
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Apetite loss (n=106)
|
2.41 Units on a Scale
Standard Deviation 0.94
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 1: Felt nauseated (n=106)
|
1.75 Units on a Scale
Standard Deviation 0.83
|
|
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Day 15: Felt nauseated (n=106)
|
1.85 Units on a Scale
Standard Deviation 0.90
|
Adverse Events
Hydromorphone HCl OROS
Serious events: 33 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydromorphone HCl OROS
n=107 participants at risk
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
5.7%
6/106 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
4.7%
5/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases tobone
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
General disorders
Asthenia
|
6.5%
7/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
General disorders
Disease progression
|
4.7%
5/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
General disorders
Fatigue
|
1.9%
2/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
General disorders
Death
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Gastrointestinal disorders
Mallory-weisssyndrome
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Infections and infestations
Septic shock
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Nervous system disorders
Comahepatic
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Psychiatric disorders
Confusional state
|
0.93%
1/107 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
Other adverse events
| Measure |
Hydromorphone HCl OROS
n=107 participants at risk
Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
51.4%
55/107 • Number of events 61 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
31.8%
34/107 • Number of events 36 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
23.4%
25/107 • Number of events 28 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.2%
12/107 • Number of events 13 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Nervous system disorders
Dizziness
|
42.1%
45/107 • Number of events 53 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
General disorders
Asthenia
|
40.2%
43/107 • Number of events 45 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.4%
25/107 • Number of events 30 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
6/107 • Number of events 6 • Baseline up to Day 15
Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
|
Additional Information
Medical Director
Medical department / Korea
Phone: +82-2-2094-4518
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place