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

March 31, 2011 updated by: Sanofi

Efficacy and Safety of Oral Ataciguat (HMR1766) 200 mg Administered Once Daily for 28 Days on Pain Reduction in Patients With Neuropathic Pain. A Randomized, Double-blind, Placebo-controlled, Cross-over Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
First period: Ataciguat - Second period: Placebo
Drug: ataciguat (HMR1766)
oral administration 200mg once daily for 28 days
Drug: placebo
oral administration once daily for 28 days
Experimental: 2
First period: Placebo - Second period: Ataciguat
Drug: ataciguat (HMR1766)
oral administration 200mg once daily for 28 days
Drug: placebo
oral administration once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in average daily pain intensity
Time Frame: after 28-days treatment
after 28-days treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Responder rate
Time Frame: after 28-days treatment
after 28-days treatment
Rescue medication intake
Time Frame: during 28-days treatment
during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: after 28-days treatment
after 28-days treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Hans-Goerg Kress, Professor, Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 27, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFI10569
  • EudraCT 2008-001518-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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