Combination analgesic development for enhanced clinical efficacy
- Conditions
- FibromyalgiaMusculoskeletal Diseases
- Registration Number
- ISRCTN14939460
- Lead Sponsor
- Canadian Institutes of Health Research (Canada), Strategy for Patient-Oriented Research (SPOR), Chronic Pain Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
1. Fibromyalgia
2. Daily pain (=3/10) for at least 3 months
3. AST/ALT =120% upper limit of normal
4. Creatinine clearance =60 ml/min
5. Necessary abilities, visual acuity, and language skills for questionnaire completion and phone communication with research personnel
6. Adults over the age of 18
1. Patients with major organ system disease, moderate to severe sedation or ataxia due to other required drugs, hypersensitivity to study medications, seizure disorder, or other painful condition >50% as severe as their fibromyalgia pain
2. Patients with a major, poorly controlled, psychiatric disorder, severe depression or suicidal ideation, or active substance abuse disorder
3. Patients who live alone and cannot assure daily contact with a friend, family member, or caregiver
4. Women of childbearing potential will be required to receive a highly effective form of contraception and a negative pregnancy test at baseline
5. Allergy or hypersensitivity to any of the study medications
6. Seizure disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean daily pain, measured using a 0-10 numerical rating scale with 0 = no pain, 10 = worst pain imaginable, averaged over the maximally tolerated dose fixed dose week (days 39-45) of each treatment period
- Secondary Outcome Measures
Name Time Method