Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain

Sponsor
Sanofi
Study ID
NCT00799656
Phase
PHASE2
Status
Completed

Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ataciguat (HMR1766) — DRUG
    oral administration 200mg once daily for 28 days
  • placebo — DRUG
    oral administration once daily for 28 days

Study Details

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.

Key Dates

Start date
Nov 30, 2008
Status verified
Mar 2011
Primary completion
Jun 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    First period: Ataciguat - Second period: Placebo
  • Experimental: 2
    First period: Placebo - Second period: Ataciguat

Primary Outcome Measure

Change in average daily pain intensity [ Time Frame: after 28-days treatment ]

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