Analgesic Drug Combinations in Neuropathic Pain (2004)

Completed

• Conditions: europathic pain; Nervous System Diseases; Neuropathic pain

• Registration Number: ISRCTN73178636
• Lead Sponsor: Canadian Institutes of Health Research (CIHR) (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Diabetic patients of either sex
2. 18 to 89 years of age
3. Distal, symmetric, sensory polyneuropathy

Exclusion Criteria

1. Neuropathy attributable to an etiology other than diabetes (e.g. hypothyroidism, vitamin B12 deficiency, connective tissue disease, amyloidosis and toxic exposure)
2. Presence of a painful condition as severe as, but distinct from, their diabetic neuropathy pain
3. Pregnancy or lactation
4. End-stage kidney or liver disease
5. Moderate to severe heart disease (Myocardial Infarction [MI] within preceding year, unstable angina, cardiac conduction defect or congestive heart failure)
6. Cardiovascular autonomic neuropathy
7. Postural hypotension more than 20 mmHg on initial assessment
8. Baseline mild to severe sedation or ataxia due to required concomitant drugs, or any other cause
9. Males with urinary symptoms attributable to benign prostatic hypertrophy
10. Presence of a seizure disorder
11. Angle-closure glaucoma
12. Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist
13. Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g. carbamazepine, oxcarbazepine)
14. Hypersensitivity to any of the study medications
15. History of significant abuse of illicit drugs, prescription drugs or alcohol
16. Lack of a primary physician
17. Patients who live alone and cannot assure daily contact with a friend, family member or caregiver

Study & Design

• Study Type: Interventional
• Study Design: Not specified