Chronic low back pain Musculoskeletal Diseases Dorsalgia
Conditions
Interventions
Oral opioid analgesic (038) titrated to effect over a four-week phase with matched placebo arm.
Sponsors
Purdue Pharma Canada
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured during the last week of treatment in each phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed