Status:
COMPLETED
Neuropathic Pain Management
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck S.A. de C.V., Mexico
Conditions:
Diabetic Neuropathies
Polyneuropathies
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 vitamin...
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 perio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01263132
Start Date
February 1 2008
End Date
February 1 2010
Last Update
February 13 2014
Active Locations (1)
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1
REMEDI Resultados Médicos Desarrollo e Investigación, S.C.
Pachuca, Hidalgo, Mexico, 42090