Neuropathic Pain Management (M-F0434)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Polyneuropathies

Diabetic Neuropathies

Treatments

Drug: F0434

Drug: Gabapentin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01263132

200057-500

Details and patient eligibility

About

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.

Full description

Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period.

OBJECTIVES

To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire.

Enrollment

104 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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