Status:
COMPLETED
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
Lead Sponsor:
Sanofi
Conditions:
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00799656
Start Date
November 1 2008
End Date
September 1 2009
Last Update
April 1 2011
Active Locations (3)
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1
Sanofi-Aventis Administrative Office
Vienna, Austria
2
Sanofi-Aventis Administrative Office
Prague, Czechia
3
Sanofi-Aventis Administrative Office
Bucharest, Romania