Study drug 020 versus placebo with acetaminophen rescue in patients with chronic low back pai

Completed

• Conditions: Low back pain; Chronic low back pain; Musculoskeletal Diseases

• Registration Number: ISRCTN06013881
• Lead Sponsor: Purdue Pharma (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity measured during the last week of treatment in each phase.

Secondary Outcome Measures

Name	Time	Method
All assessments measured during the last week of treatment in each phase:<br>1. Pain and disability <br>2. Pain and sleep <br>3. Quality of life <br>4. Functional disability