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

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: ataciguat (HMR1766); Drug: placebo

• Registration Number: NCT00799656
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-27
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.

Exclusion Criteria

• Presence or history of cancer within the past five years
• Patients with a history of HIV infection
• Patients with active hepatitis B or C
• Patients with any pain other than the neuropathic pain of greater or equal severity
• Patients with a diabetes mellitus for less than 6 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	ataciguat (HMR1766)	First period: Placebo - Second period: Ataciguat
1	ataciguat (HMR1766)	First period: Ataciguat - Second period: Placebo
1	placebo	First period: Ataciguat - Second period: Placebo
2	placebo	First period: Placebo - Second period: Ataciguat

Primary Outcome Measures

Name	Time	Method
Change in average daily pain intensity	after 28-days treatment

Secondary Outcome Measures

Name	Time	Method
Responder rate	after 28-days treatment
Rescue medication intake	during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)	after 28-days treatment

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇷🇴 Bucuresti, Romania