A randomised, placebo-controlled, titration-to-effect, crossover study of study drug 038 in patients with chronic low back pain
ISRCTN | ISRCTN35931095 |
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DOI | https://doi.org/10.1186/ISRCTN35931095 |
Secondary identifying numbers | 038-001 |
- Submission date
- 12/06/2008
- Registration date
- 04/07/2008
- Last edited
- 13/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
L1W 3W8
Canada
Study information
Study design | Multi-centred, randomised, double-blind, placebo-controlled crossover trial |
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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. Please have your family physician use the contact details below to request information on the study. |
Scientific title | |
Study objectives | Study drug 038 will be superior to placebo on the treatment of chronic low back pain. |
Ethics approval(s) | Ethics approval for the lead centre was received from IRB Services, Aurora, Ontario (Canada) on December 1, 2006. All other participating centres obtained ethics approval before recruiting study participants. |
Health condition(s) or problem(s) studied | Chronic low back pain |
Intervention | Oral opioid analgesic (038) titrated to effect over a four-week phase with matched placebo arm. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Study drug 038 |
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. Quebec Back Pain 2. Pain and sleep 3. Pain and disability 4. Quality of life 5. Bowel function |
Overall study start date | 01/12/2006 |
Completion date | 30/04/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 100 |
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 require opioids to control their pain |
Key exclusion criteria | 1. Patients who may require more than 12 tables of Tylenol No. 3 per day 2. Patients whose pain is expected to be refractory to opioid therapy 3. Patients with intolerance to study drug 038, acetaminophen or any other opioid 4. Patients with significant sources of unrelated pain that may obscure the assessment of efficacy 5. Patients with any of the following medical conditions: 5.1. Risk for central nervous system (CNS) and/or respiratory depression 5.3. Active inflammatory gastrointestinal disease 5.4. Peptic ulcer disease 5.5. Major psychiatric disorder 5.6. Any condition that may obscure patient safety or efficacy assessment 5.7. Patients who have received an investigational drug within the last month |
Date of first enrolment | 01/12/2006 |
Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
Purdue Pharma
Pickering
L1W 3W8
Canada
L1W 3W8
Canada
Sponsor information
Purdue Pharma Canada
Industry
Industry
c/o Dr. John Eisenhoffer
575 Granite Court
Pickering
L1W 3W8
Canada
Phone | +1 905 420 6400 |
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medinfo@purdue.ca | |
Website | http://www.purdue.ca |
https://ror.org/023sxys58 |
Funders
Funder type
Industry
Purdue Pharma Canada
No information available
Results and Publications
Intention to publish date | |
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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 |