Neuropathic Pain Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study

Conditions
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Diabetic Neuropathies, Polyneuropathies

Intervention / Treatment
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* Drug: F0434
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F0434<br> | Drug: F0434<br>* F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).<br>* Other names: Gabapentin with thiamine and cobalamin;|
| Active Comparator: Gabapentin<br> | Drug: Gabapentin<br>* Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)<br>* Other names: Gavindo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Neuropathic Pain Score at 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. | Visit 3 (Week 1) | 
| Mean Neuropathic Pain Score at 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. | Visit 4 (Week 2) | 
| Mean Neuropathic Pain Score at 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. | Visit 5 (Week 3) | 
| Mean Neuropathic Pain Score at 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. | Visit 6 (Week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | 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. | Visit 2 (Baseline) to Visit 6 (Week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyneuropathy, Diabetes Mellitus, Diabetic peripheral neuropathy