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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose Response and Efficacy of GW842166 in Pain

NCT00554762

Healthy Subjects

WITHDRAWN PHASE1

Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia

NCT01058642

Postherpetic Neuralgia

TERMINATED PHASE2

Efficacy of Etoricoxib on Peripheral Hyperalgesia

NCT01088256

Causalgia Polyneuropathy Postherpetic Neuralgia +2 more

TERMINATED PHASE2

Phase II Dose Titration Study in Patients With Neuropathic Pain

NCT00736151

Neuropathic Pain

COMPLETED PHASE2

Titration Study of ABX-1431

NCT03447756

Post Herpetic Neuralgia Diabetic Peripheral Neuropathy Small Fiber Neuropathy +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

First period: Ataciguat - Second period: Placebo

Group Type EXPERIMENTAL

ataciguat (HMR1766)

Intervention Type DRUG

oral administration 200mg once daily for 28 days

placebo

Intervention Type DRUG

oral administration once daily for 28 days

2

First period: Placebo - Second period: Ataciguat

Group Type EXPERIMENTAL

ataciguat (HMR1766)

Intervention Type DRUG

oral administration 200mg once daily for 28 days

placebo

Intervention Type DRUG

oral administration once daily for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ataciguat (HMR1766)

oral administration 200mg once daily for 28 days

Intervention Type DRUG

placebo

oral administration once daily for 28 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No