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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: placebo; Drug: ataciguat (HMR1766)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799656

EudraCT 2008-001518-26

DFI10569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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62 participants in 2 patient groups

1

Experimental group

Description:

First period: Ataciguat - Second period: Placebo

Treatment:

Drug: ataciguat (HMR1766)

Drug: placebo

2

Experimental group

Description:

First period: Placebo - Second period: Ataciguat

Treatment:

Drug: ataciguat (HMR1766)

Drug: placebo