Trial Outcomes & Findings for An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain (NCT NCT01205126)
NCT ID: NCT01205126
Last Updated: 2014-02-03
Results Overview
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2014-02-03
Participant Flow
Participant milestones
| Measure |
Hydromorphone Hydrochloride (HCl)
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Titration Phase
STARTED
|
130
|
130
|
|
Titration Phase
COMPLETED
|
107
|
111
|
|
Titration Phase
NOT COMPLETED
|
23
|
19
|
|
Between Titration & Maintenance Phase
STARTED
|
107
|
111
|
|
Between Titration & Maintenance Phase
COMPLETED
|
107
|
107
|
|
Between Titration & Maintenance Phase
NOT COMPLETED
|
0
|
4
|
|
Maintenance Phase
STARTED
|
107
|
107
|
|
Maintenance Phase
COMPLETED
|
70
|
67
|
|
Maintenance Phase
NOT COMPLETED
|
37
|
40
|
Reasons for withdrawal
| Measure |
Hydromorphone Hydrochloride (HCl)
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Titration Phase
Adverse Event
|
5
|
3
|
|
Titration Phase
Withdrawal by Subject
|
5
|
5
|
|
Titration Phase
Lost to Follow-up
|
2
|
2
|
|
Titration Phase
No stable titration dose
|
1
|
0
|
|
Titration Phase
More than maximum dosage required
|
2
|
3
|
|
Titration Phase
Other
|
8
|
6
|
|
Between Titration & Maintenance Phase
Other
|
0
|
4
|
|
Maintenance Phase
Adverse Event
|
3
|
7
|
|
Maintenance Phase
Death
|
4
|
4
|
|
Maintenance Phase
More than the maximum dosage required
|
5
|
5
|
|
Maintenance Phase
Prohibited drugs used
|
1
|
0
|
|
Maintenance Phase
Other
|
11
|
8
|
|
Maintenance Phase
Lost to Follow-up
|
5
|
5
|
|
Maintenance Phase
Withdrawal by Subject
|
8
|
11
|
Baseline Characteristics
An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
Baseline characteristics by cohort
| Measure |
Hydromorphone Hydrochloride (HCl)
n=125 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=123 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
53.1 Years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication.
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (HCl)
n=40 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=41 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29
Baseline
|
6.7 Units on a scale
Standard Deviation 1.80
|
6.9 Units on a scale
Standard Deviation 1.65
|
|
Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29
Change at Day 29
|
-1.8 Units on a scale
Standard Deviation 2.79
|
-1.8 Units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (HCl)
n=40 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=41 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
Baseline
|
2.4 Units on a scale
Standard Deviation 1.63
|
2.3 Units on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
Change at Day 29
|
-0.8 Units on a scale
Standard Deviation 1.59
|
-0.5 Units on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (HCl)
n=40 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=41 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
Baseline
|
4.7 Units on a scale
Standard Deviation 1.35
|
4.7 Units on a scale
Standard Deviation 1.46
|
|
Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
Change at Day 29
|
-1.8 Units on a scale
Standard Deviation 1.98
|
-1.4 Units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (HCl)
n=40 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=41 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29
Baseline
|
4.1 Units on a scale
Standard Deviation 2.09
|
4.1 Units on a scale
Standard Deviation 2.19
|
|
Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29
Change at Day 29
|
-1.4 Units on a scale
Standard Deviation 2.60
|
-1.4 Units on a scale
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (HCl)
n=40 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=41 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29
Baseline
|
48.8 Units on a scale
Standard Deviation 25.54
|
48.0 Units on a scale
Standard Deviation 23.05
|
|
Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29
Change at Day 29
|
15.8 Units on a scale
Standard Deviation 31.29
|
14.1 Units on a scale
Standard Deviation 32.01
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure.
Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (HCl)
n=36 Participants
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=40 Participants
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Breakthrough Pain Medication (Rescue Medication) Doses Taken
|
24.2 Doses
Standard Deviation 24.41
|
29.3 Doses
Standard Deviation 24.33
|
Adverse Events
Hydromorphone Hydrochloride (HCl)
Serious events: 11 serious events
Other events: 102 other events
Deaths: 0 deaths
Oxycodone HCl Controlled Release (CR)
Serious events: 18 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydromorphone Hydrochloride (HCl)
n=128 participants at risk
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=126 participants at risk
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.00%
0/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.00%
0/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
General disorders
Chest pain
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.00%
0/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
General disorders
Death
|
2.3%
3/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
General disorders
Disease progression
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Hepatobiliary disorders
Coma hepatic
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Infections and infestations
Pneumonia
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.00%
0/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.00%
0/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
1.6%
2/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
1.6%
2/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Renal and urinary disorders
Renal failure acute
|
0.78%
1/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.00%
0/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
2/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
0.79%
1/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
Other adverse events
| Measure |
Hydromorphone Hydrochloride (HCl)
n=128 participants at risk
Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
Oxycodone HCl Controlled Release (CR)
n=126 participants at risk
Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
7.0%
9/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
7.1%
9/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
11/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
8.7%
11/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
4/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
5.6%
7/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.5%
7/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
5.6%
7/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Constipation
|
33.6%
43/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
35.7%
45/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
12/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
7.1%
9/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Nausea
|
33.6%
43/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
35.7%
45/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Gastrointestinal disorders
Vomiting
|
33.6%
43/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
37.3%
47/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
General disorders
Asthenia
|
8.6%
11/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
7.1%
9/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
General disorders
Oedema peripheral
|
8.6%
11/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
4.8%
6/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
General disorders
Pyrexia
|
18.8%
24/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
21.4%
27/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
4/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
5.6%
7/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Investigations
Neutrophil count decreased
|
5.5%
7/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
4.0%
5/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Investigations
Platelet count decreased
|
6.2%
8/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
5.6%
7/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Investigations
White blood cell count decreased
|
10.2%
13/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
13.5%
17/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
7.0%
9/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
4.0%
5/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.6%
20/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
16.7%
21/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Nervous system disorders
Dizziness
|
16.4%
21/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
17.5%
22/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Nervous system disorders
Somnolence
|
8.6%
11/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
11.1%
14/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
7.0%
9/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
4.8%
6/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
3/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
6.3%
8/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
7/128 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
3.2%
4/126 • Screening phase up to 30 days after last dose of study medication
Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.
|
Additional Information
Director, Established Products
Janssen Research & Development, LLC
Phone: +1 609 730 3387;
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60