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Completed

NCT Number: NCT00799656

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

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.

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Key information

Conditions

Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ataciguat (HMR1766)

Drug

oral administration 200mg once daily for 28 days

Placebo

Drug

oral administration once daily for 28 days

Primary outcomes

  1. Change in average daily pain intensity

    Time frame: after 28-days treatment

Secondary outcomes

  1. Responder rate

    Time frame: after 28-days treatment

  2. Rescue medication intake

    Time frame: during 28-days treatment

  3. Change in Neuropathic Pain Symptom Inventory (NPSI)

    Time frame: after 28-days treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: SERENEATI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 1, 2008
Registry last updated
Apr 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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