Study drug 020 versus placebo with acetaminophen rescue in patients with chronic low back pain
| ISRCTN | ISRCTN06013881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06013881 |
| Secondary identifying numbers | 020-007 |
- Submission date
- 25/03/2008
- Registration date
- 04/07/2008
- Last edited
- 06/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Eisenhoffer
Scientific
Scientific
Purdue Pharma
575 Granite Court
Pickering, Ontario
L1W 3W8
Canada
| Phone | +1 905 420 6400 |
|---|---|
| medinfo@purdue.ca |
Study information
| Study design | Multi-centred, randomised, double-blind, placebo-controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Study drug 020 will be superior to placebo in the treatment of chronic low back pain. |
| Ethics approval(s) | Ethics approval for the lead centre was received from the Mount Sinai Hospital Research Ethics Board (REB), Toronto, ON (Canada) on 3rd August 2004. All other participating centres obtained ethics approval before recruiting study participants. |
| Health condition(s) or problem(s) studied | Chronic low back pain |
| Intervention | Transdermal opioid analgesic (020) titrated to effect over a four-week phase with matched placebo arm, with acetaminophen rescue (325 - 650 mg every four to six hours as and when needed [q4 - 6h prn]) provided in both arms. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Study drug 020 (buprenorphine transdermal system), acetaminophen |
| Primary outcome measure | Pain intensity measured during the last week of treatment in each phase. |
| Secondary outcome measures | All assessments measured during the last week of treatment in each phase: 1. Pain and disability 2. Pain and sleep 3. Quality of life 4. Functional disability |
| Overall study start date | 05/07/2004 |
| Completion date | 03/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Male or non-pregnant females at least 18 years of age 2. Chronic low back pain of at least moderate intensity for at least three months 3. Patients who have not responded adequately to non-opioid analgesics and are currently taking a minimum of one tablet per day of an opioid analgesic |
| Key exclusion criteria | 1. Patients with intolerance to study drug 020, acetaminophen or any opioid 2. Patients expected to require more than 12 tablets of Tylenol no. 3 per day 3. Patients whose pain is expected to be refractory to opioid therapy 4. Patients who require therapy involving direct external heat sources 5. Patients with a significant source of unrelated pain that may obscure the assessment of efficacy 6. Patients with any of the following medical conditions: 6.1. Renal or hepatic impairment 6.2. Risk of respiratory depression 6.3. Peptic ulcer disease 6.4. Active inflammatory gastrointestinal disease 6.5. Major psychiatric disorder 6.6. Congenital Long QT syndrome, or any family member with this condition 6.7. History of congestive heart failure, atrial fibrillation, myocardial ischaemia, tachycardia (greater than 100 bpm at rest) or bradycardia (less than 45 bmp at rest) 6.8. Decreased serum magnesium or potassium 6.9. Any condition that would obscure patient safety or efficacy assessment 7. Patients currently receiving any of the following: 7.1. Class IA anti-arrhythmic medications (e.g., quinidine, procainamide, disopyramide) 7.2. Class III anti-arrhythmic medications (e.g., sotalol, amiodarone) 7.3. Any medication known to cause torsades de pointes 8. Patients who received an investigational drug within the past month |
| Date of first enrolment | 05/07/2004 |
| Date of final enrolment | 03/03/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Purdue Pharma
Pickering, Ontario
L1W 3W8
Canada
L1W 3W8
Canada
Sponsor information
Purdue Pharma (Canada)
Industry
Industry
575 Granite Court
Pickering, Ontario
L1W 3W8
Canada
| Website | http://www.purdue.ca/main/ |
|---|---|
"ROR" |
https://ror.org/023sxys58 |
Funders
Funder type
Industry
Purdue Pharma (Canada)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
