Pain improvement with novel combination analgesic regimens
- Conditions
- europathic painSigns and Symptoms
- Registration Number
- ISRCTN14577546
- Lead Sponsor
- Canadian Institutes of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
1. Neuropathic pain
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. Glycosylated hemoglobin =9.5%
6. Necessary abilities, visual acuity, and language skills for questionnaire completion and phone communication with research personnel
7. Adults between the ages of 18 to 89
1. Patients with major organ system disease, cardiovascular autonomic neuropathy, 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 neuropathic 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
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