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

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: ataciguat (HMR1766)
* Drug: placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>First period: Ataciguat - Second period: Placebo | Drug: ataciguat (HMR1766)<br>* oral administration 200mg once daily for 28 days<br>Drug: placebo<br>* oral administration once daily for 28 days<br>|
| Experimental: 2<br>First period: Placebo - Second period: Ataciguat | Drug: ataciguat (HMR1766)<br>* oral administration 200mg once daily for 28 days<br>Drug: placebo<br>* oral administration once daily for 28 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average daily pain intensity |  | after 28-days treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate |  | after 28-days treatment | 
| Rescue medication intake |  | during 28-days treatment | 
| Change in Neuropathic Pain Symptom Inventory (NPSI) |  | after 28-days treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic neuropathy, painful pain, postoperative