Neuropathic Pain Management
CompletedPhase 3NCT01263132
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study
- Conditions
- Diabetic Neuropathies
- Polyneuropathies
- Interventions
- Drug: F0434
- Drug: Gabapentin
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Collaborators
- Merck S.A. de C.V., Mexico
- Start date
- 2008-02
- Primary completion
- 2010-02
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Mexico
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01263132