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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
History of Changes

November 27, 2008
March 31, 2011
November 2008
June 2009   (final data collection date for primary outcome measure)
Change in average daily pain intensity [ Time Frame: after 28-days treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00799656 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: ataciguat (HMR1766)
    oral administration 200mg once daily for 28 days
  • Drug: placebo
    oral administration once daily for 28 days
  • Experimental: 1
    First period: Ataciguat - Second period: Placebo
    Interventions:
    • Drug: ataciguat (HMR1766)
    • Drug: placebo
  • Experimental: 2
    First period: Placebo - Second period: Ataciguat
    Interventions:
    • Drug: ataciguat (HMR1766)
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Romania
 
NCT00799656
DFI10569, EudraCT 2008-001518-26
No
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Principal Investigator: Hans-Goerg Kress, Professor Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien
Sanofi
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP