A randomised, crossover study of study drug 038 and controlled-release oxycodone HCl tablets in patients with chronic non-cancer pain
| ISRCTN | ISRCTN76170309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76170309 |
| Protocol serial number | 038-002 |
| Sponsor | Purdue Pharma Canada |
| Funder | Purdue Pharma Canada (Canada) |
- Submission date
- 09/12/2008
- Registration date
- 08/01/2009
- Last edited
- 10/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paula Piraino
Scientific
Scientific
Purdue Pharma
575 Granite Court
Pickering, Ontario
L1W 3W8
Canada
| Phone | +1 905 420 6400 |
|---|---|
| paula.piraino@purdue.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blind crossover trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Study drug 038 will be superior to controlled-release (CR) oxycodone on bowel function and not inferior to CR oxycodone in pain control in patients with chronic non-cancer pain. As of 13/08/2010 this record was updated to include an extended end date; the initial anticipated end date at the time of registration was 15/09/2009. As of 10/01/2011 this record was again updated to include an extended end date; the previous anticipated end date at the time of registration was 31/03/2011. |
| Ethics approval(s) | Lead centre received approval from IRB Services, Aurora, Ontario (Canada) on 10 June 2008 |
| Health condition(s) or problem(s) studied | Chronic non-cancer pain and bowel function |
| Intervention | Oral opioid analgesic (038) titrated to effect over a five-week phase with matched CR oxycodone arm. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Study drug 038, controlled-release oxycodone HCl |
| Primary outcome measure(s) |
Pain intensity and bowel function measured during the last week of treatment in each phase. |
| Key secondary outcome measure(s) |
All assessments measured during the last week of treatment in each phase: |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Male or non-pregnant, non-nursing female patients over the age of 18 years with chronic non-cancer pain of moderate or greater intensity for at least three months 2. Patients who require stable doses of 60 to 80 mg every 12 hours of oxycodone or its analgesic equivalent 3. Patients experiencing less than three complete, spontaneous bowel movements in the seven days prior to randomisation |
| Key exclusion criteria | 1. Patients who undergoing any treatments that may change their pain during the study, such as physiotherapy, corticosteroid injections or surgical procedures 2. Patients who do not respond adequately to doses of 60 or 80 mg every 12 hours of oxycodone 3. Patients whose pain is expected to be refractory to continuous opioid therapy 4. Patients with allergy to study drug 038, oxycodone or any other opioid 5. Patients with any of the following: 5.1. A condition that affects patient safety or obscures the assessment of efficacy 5.2. Compromised kidney or liver function 5.3. Risk for central nervous system (CNS) and/or respiratory depression 5.4. Significant gastrointestinal structural abnormalities or diseases/conditions that affect bowel function 5.5. A major psychiatric disorder 5.6. Received an investigational drug in the last month 5.7. Failed the urine drug screen |
| Date of first enrolment | 31/07/2008 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
Purdue Pharma
Pickering, Ontario
L1W 3W8
Canada
L1W 3W8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
