Neuropathic Pain Management

Phase 3

Completed

Conditions: Diabetic Neuropathies
Polyneuropathies

Interventions: Drug: F0434
Drug: Gabapentin

Registration Number: NCT01263132

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 104

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F0434	F0434	-
Gabapentin	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Mean Neuropathic Pain Score at Visit 3 (Week 1)	Visit 3 (Week 1)	Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Mean Neuropathic Pain Score at Visit 4 (Week 2)	Visit 4 (Week 2)	Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Mean Neuropathic Pain Score at Visit 5 (Week 3)	Visit 5 (Week 3)	Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Mean Neuropathic Pain Score at Visit 6 (Week 4)	Visit 6 (Week 4)	Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire	Visit 2 (Baseline) to Visit 6 (Week 4)	SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.