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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00799656
First received: November 27, 2008
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Pain
Drug: ataciguat (HMR1766)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in average daily pain intensity [ Time Frame: after 28-days treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate [ Time Frame: after 28-days treatment ] [ Designated as safety issue: No ]
  • Rescue medication intake [ Time Frame: during 28-days treatment ] [ Designated as safety issue: No ]
  • Change in Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: after 28-days treatment ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799656

Locations
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Hans-Goerg Kress, Professor Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00799656     History of Changes
Other Study ID Numbers: DFI10569, EudraCT 2008-001518-26
Study First Received: November 27, 2008
Last Updated: March 31, 2011
Health Authority: Romania: National Medicines Agency
Austria: Agency for Health and Food Safety
Czech Republic: Ethics Committee

Keywords provided by Sanofi:
Diabetic neuropathy
painful pain
postoperative

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014