Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

Avanir Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Diabetic Neuropathy

Pain

Treatments

Drug: Neurodex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113620

04-AVR-109

Details and patient eligibility

About

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of diabetes mellitus
Established diabetic therapy for at least 3 months
Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
Pain the previous three months
Not pregnant

Exclusion criteria

Patient failed adequate trial of 3 or more medications or has required narcotics for pain
History of torsades de pointes
Sensitivity to quinidine or opiate drugs (codeine, etc)
Severe pain that could confound the assessment
Patient has had any amputations
Patient has participated in the past 30 days or is currently participating in another trial
Patient has previously received treatment with dextromethorphan and quinidine