Back to resultsEfficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain (SERENEATI)
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ataciguat (HMR1766)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Diabetic neuropathy, painful pain, postoperative
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
First period: Ataciguat - Second period: Placebo
First period: Placebo - Second period: Ataciguat
Outcomes
Primary Outcome Measures
Change in average daily pain intensity
Secondary Outcome Measures
Responder rate
Rescue medication intake
Change in Neuropathic Pain Symptom Inventory (NPSI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00799656
Brief Title
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
Acronym
SERENEATI
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Diabetic neuropathy, painful pain, postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
First period: Ataciguat - Second period: Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
First period: Placebo - Second period: Ataciguat
Intervention Type
Drug
Intervention Name(s)
ataciguat (HMR1766)
Intervention Description
oral administration 200mg once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration once daily for 28 days
Primary Outcome Measure Information:
Title
Change in average daily pain intensity
Time Frame
after 28-days treatment
Secondary Outcome Measure Information:
Title
Responder rate
Time Frame
after 28-days treatment
Title
Rescue medication intake
Time Frame
during 28-days treatment
Title
Change in Neuropathic Pain Symptom Inventory (NPSI)
Time Frame
after 28-days treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Goerg Kress, Professor
Organizational Affiliation
Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Wien
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
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