Study of PRC-062 in patients with chronic non-cancer pain
| ISRCTN | ISRCTN54273961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54273961 |
| Secondary identifying numbers | 062-010 |
- Submission date
- 11/11/2013
- Registration date
- 20/12/2013
- Last edited
- 20/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
The purpose of this study is to see if a drug called PRC-062 works as well as the drug named CR hydromorphone in treating chronic non-cancer pain.
Who can participate?
Adults taking CR hydromorphone for the treatment of chronic non-cancer pain for at least 3 months can participate in this study.
What does the study involve?
The study has two phases. In the first phase all participants will receive CR hydromorphone. In the second phase participants will be randomly allocated to receive either CR hydromorphone or PRC-062. They will be followed up at their clinic visits.
What are the possible benefits and risks of participating?
Participation in this study will provide important information on the safety and effectiveness of PRC-062, which may benefit other patients with chronic pain. The main risks are expected to be similar to those associated with the regular use of CR hydromorphone.
Where is the study run from?
The study is run in clinics located in Canada.
When is the study starting and how long is it expected to run for?
The study started in November 2013 and is expected to run for approximately one year.
Who is funding the study?
Purdue Pharma, Canada.
Who is the main contact?
Purdue Pharma Product Information
productinfo@purdue.ca
Contact information
Scientific
575 Granite Court
Pickering, Ontario
L1W 3W8
Canada
Study information
| Study design | Multicenter randomized double-blind active-controlled parallel arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Interested patients may have their family physician use the contact details below to request information on the study. |
| Scientific title | Phase III, randomized, double-blind, active-controlled, parallel arm study of PRC-062 in patients with chronic non-cancer pain |
| Study objectives | PRC-062 at equal doses is as effective as CR hydromorphone in maintaining pain control in subjects with stable chronic non-cancer pain. |
| Ethics approval(s) | Institutional Review Board (IRB) Services, Aurora, Ontario, Canada, 11/09/2013 |
| Health condition(s) or problem(s) studied | Chronic non-cancer pain |
| Intervention | The duration of the study is six weeks. In the first phase all subjects will receive CR hydromorphone. In the second phase, subjects will be randomized to receive either CR hydromorphone or PRC-062 and will be followed-up at weekly clinic visits. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | PRC-062, CR hydromorphone |
| Primary outcome measure | Proportion of subjects in each arm who require a dose change from their pre-randomization CR hydromorphone dose, irrespective of when during the post-randomization period this dose change occurs |
| Secondary outcome measures | 1. Magnitude of the mean dose change between treatment arms 2. Within-subject magnitude of the dose change from pre- to post-randomization 3. Rescue medication usage 4. Pain Intensity Questionnaire (PIQ), at weekly visits during the study 5. Beck Depression Inventory (BDI), at weekly visits during the study 6. Pain and Sleep Questionnaire 3 Item Index (PSQ-3), at weekly visits during the study 7. Pain and Disability Index (PDI), at weekly visits during the study 8. Treatment effectiveness and satisfaction, at weekly visits during the study 9. Global Impression of Change (GIC) scale, at weekly visits during the study 10. Subjective Opiate Withdrawal Scale (SOWS), at weekly visits during the study 11. Quality of life (SF-12) questionnaire, at weekly visits during the study 12. Brief Pain Inventory (BPI), at weekly visits during the study 13. Bowel Function Index (BFI), at weekly visits during the study 14. Laxative use The secondary endpoints of magnitude of the mean dose change between treatment arms, the within-subject magnitude of the dose change from pre- to post-randomization, laxative use and rescue medication use will be captured irrespective of when during the post-randomization period these changes occur. The mean change from baseline in all endpoints will be measured. |
| Overall study start date | 01/11/2013 |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Male or non-pregnant, non-nursing female subjects of 18 years of age or older 2. History of chronic non-cancer pain for six months or more 3. Subjects who at time of screening require stable doses of CR hydromorphone not exceeding 60 mg per day for a period of three months or more prior to entry into the study and who report satisfaction with their pain management |
| Key exclusion criteria | 1. Subjects who do not respond adequately to on-label dosing of CR hydromorphone at doses not exceeding 60 mg per day 2. Subjects with cancer 3. Inhaled cannabis use 4. Compromised kidney or liver function 5. Conditions that may adversely affect safety or obscure the assessment of efficacy 6. Risk for central nervous system (CNS) or respiratory depression 7. Significant gastrointestinal (GI) structural abnormalities or diseases/conditions that may affect bowel function 8. Major psychiatric disorder 9. Received an investigational drug in the past month 10. Taking monoamine oxidase (MAO) inhibitors |
| Date of first enrolment | 01/11/2013 |
| Date of final enrolment | 31/07/2014 |
Locations
Countries of recruitment
- Canada
Study participating centre
L1W 3W8
Canada
Sponsor information
Industry
575 Granite Court
Pickering, Ontario
L1W 3W8
Canada
| productinfo@purdue.ca | |
"ROR" |
https://ror.org/023sxys58 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
