Efficacy and Safety Study of Ataciguat Versus Placebo in... | NCT00799656

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

NCT00799656

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 1, 2011Estimated

Enrollment

62Actual

Phase

Phase 2

Conditions

Pain

Interventions

ataciguat (HMR1766)
placebo

Countries

Austria
Czechia
Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2008-001518-26

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Nov 27, 2008

First Submission Date that Met QC Criteria

Nov 28, 2008

First Posted Date

Dec 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2011

Last Update Posted Date

Apr 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	First period: Ataciguat - Second period: Placebo	Drug: ataciguat (HMR1766) Drug: placebo
2	Experimental	First period: Placebo - Second period: Ataciguat	Drug: ataciguat (HMR1766) Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ataciguat (HMR1766)	Drug	oral administration 200mg once daily for 28 days	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans-Goerg Kress, Professor	Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Vienna			Austria
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010523	Peripheral Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C515616	5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided