The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain. The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.
This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
oral administration 200mg once daily for 28 days
oral administration once daily for 28 days
Sanofi-Aventis Administrative Office
Vienna, Austria
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Bucharest, Romania
Change in average daily pain intensity
Time frame: after 28-days treatment
Responder rate
Time frame: after 28-days treatment
Rescue medication intake
Time frame: during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)
Time frame: after 28-days treatment
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