Diabetic Neuropathies Clinical Trial
Official title:
Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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