Diabetic Neuropathic Pain Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized, Parallel-group Study Evaluating the Efficacy and Tolerability of Oral BVT.115959, a Novel A2A Agonist, Versus Placebo in the Treatment of Diabetic Neuropathic Pain
The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.
The planned study is an exploratory study which aims to provide proof of the efficacy of
BVT.115959 in the reduction of the symptoms of pain. Thus, the primary objective is to
evaluate the anticipated analgesic properties of BVT.115959 in patients with diabetic
neuropathic pain and to confirm its activity against placebo.
The study will evaluate the efficacy and tolerability of oral BVT.115959 7 mg administered
three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic
pain who are either not on analgesia or are on stable analgesia in the month prior to
entering the study and who are being maintained on stable analgesia throughout the study.
Eligible subjects will be randomized in a ratio of 2:1 (BVT.115959: placebo).
The study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1
week follow-up period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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