Trial Outcomes & Findings for A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain (NCT NCT00803283)
NCT ID: NCT00803283
Last Updated: 2013-08-12
Results Overview
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
TERMINATED
PHASE3
2 participants
Day 14
2013-08-12
Participant Flow
Participant milestones
| Measure |
Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)
Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
|
Morphine Sustain Release (SR)
Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain
Baseline characteristics by cohort
| Measure |
Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)
n=1 Participants
Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
|
Morphine Sustain Release (SR)
n=1 Participants
Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 to <=40 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
>=41 to <=60 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 22 and Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 "how much pain you have right now" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 22 and Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item "Pain Intensity" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 22 and Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item "Pain Relief" will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 22 and Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item "Pain Interference" will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14, Day 22 and Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Participants will evaluate effectiveness by providing rating on the question "'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase" using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14, Day 22 and Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Investigator will evaluate effectiveness by providing rating on the question "'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase" using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to day 28Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Mean total daily dose of study medication taken during study will be recorded by participants.
Outcome measures
Outcome data not reported
Adverse Events
Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)
Morphine Sustain Release (SR)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)
n=1 participants at risk
Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
|
Morphine Sustain Release (SR)
n=1 participants at risk
Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
100.0%
1/1 • Baseline up to Day 28
|
0.00%
0/1 • Baseline up to Day 28
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Baseline up to Day 28
|
0.00%
0/1 • Baseline up to Day 28
|
|
Gastrointestinal disorders
Chest discomfort
|
100.0%
1/1 • Baseline up to Day 28
|
0.00%
0/1 • Baseline up to Day 28
|
|
Gastrointestinal disorders
Abdominal distension
|
100.0%
1/1 • Baseline up to Day 28
|
0.00%
0/1 • Baseline up to Day 28
|
Additional Information
Medical Advisor
Janssen Taiwan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60