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

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799656
• Other study ID #: DFI10569
• Secondary ID: EudraCT 2008-001
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2008
• Last updated: March 31, 2011
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines AgencyAustria: Agency for Health and Food SafetyCzech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Drug:
• ataciguat (HMR1766)
oral administration 200mg once daily for 28 days
• placebo
oral administration once daily for 28 days

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Wien
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Romania	Sanofi-Aventis Administrative Office	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  Czech Republic,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average daily pain intensity		after 28-days treatment	No
Secondary	Responder rate		after 28-days treatment	No
Secondary	Rescue medication intake		during 28-days treatment	No
Secondary	Change in Neuropathic Pain Symptom Inventory (NPSI)		after 28-days treatment	No