Chronic low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
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])
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 have not responded adequately to non-opioid analgesics and are currently taking a minimum of one tablet per day of an opioid analgesic
Exclusion criteria
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
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. Pain and disability 2. Pain and sleep 3. Quality of life 4. Functional disability | — |
Countries
Canada
Outcome results
None listed