Neuropathic Pain Management
Condition: Diabetic Neuropathies; Polyneuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies; Polyneuropathies
Intervention: F0434; Gabapentin
Intervention description: 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).; 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)
Intervention MeSH terms: Thiamine; Vitamin B 12; Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Polyneuropathy; Diabetes Mellitus; Diabetic peripheral neuropathy

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.
    

Eligibility 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