Neuropathic Pain Management

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck S.A. de C.V., Mexico
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Thiamine; Vitamin B 12

Criteria

Inclusion Criteria:

• Subjects diagnosed with diabetes mellitus type 2

• Subjects with a history of neuropathic pain in the last 3 Months

• Men and women in reproductive age with a family planning method

• Subjects aged between 18 to 70 years

• Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%

• Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit

Exclusion Criteria:

• Subjects diagnosed as being pregnant or in state of lactation

• Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min

• Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes

• Subjects who are being pharmacologically treated for epilepsy

• Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes

• Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study

• Subjects with any orthopaedic alteration of any extremity

• Subjects with peripheral artery disease

• Subjects taking more than two neuropathic pain medicines

• Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse

• Subjects with acid-peptic disease

• Subjects with history of neoplasm of any type