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. - SERENEATI

• Conditions: The proposed study is planned to demonstrate that ataciguat 200 mg/day could be effective in reducing neuropathic pain with a good safety profile; MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

• Registration Number: EUCTR2008-001518-26-AT
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The study will include adult patients of either gender, 18 – 75 years of age, who have signed the informed consent form, and presenting with chronic neuropathic pain due to diabetic polyneuropathy or a peripheral nerve lesion following a surgical intervention such as inguinal hernia repair, thoracotomy, coronary artery bypass surgery or orthopedic limb surgery. The neuropathic pain must have a distinct neuroanatomically plausible distribution demonstrated by at least one confirmatory test (e.g. clinical sensory examination, electrophysiology) and be present for more than 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

7.3.1 Exclusion criteria related to study methodology

•Patients age at time of screening below limit of legal majority or older than 75 years;
•Patients who are illiterate or are judged by the investigator to be unable or unlikely to understand the nature, scope and possible consequences of the study;
•Patients with a history of multiple allergic reactions to drugs;
•Patients with short life expectancy;
•Patients with severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication according to investigator’s medical judgment;
•Serum creatinine >150 µmol/L;
•Presence of signs of clinically significant abnormalities on a standard electrocardiogram (ECG) recording at the screening visit according to investigator’s medical judgment (e.g., QTc = 500 ms);
•Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer;
•Patients with a history of HIV infection;
•Patients with active hepatitis B or C;
•Patients with abnormal folate, vitamin B12 or elevated TSH (hypothyroidism) that could be the cause of the neuropathic pain, and need to be corrected;
•Patients with diabetes mellitus and time between diagnosis of diabetes and enrolment <6 months;
•Patients with diabetes mellitus and HbA1c >11%;
•Patients with an average daily pain intensity for their neuropathic pain <4 on the 11-point NRS over the last 3 days before randomization;
•Patients with any pain other than the neuropathic pain of equal or greater severity;
•Sensory polyneuropathy post chemotherapy or in the context of cancer or AIDS;
•Patients with previous treatment failure to several approved treatment regimens for neuropathic pain of adequate doses and duration;
•Patients with a complex regional pain syndrome;
•Patients with chronic post-radiculopathic syndrome;
•Patients with trigeminus neuralgia;
•Neurologic deficits diagnosed within one month prior to the study and considered to be progredient throughout the duration of the study;
•Pregnant or breastfeeding women;
•Women of child-bearing potential are excluded unless they meet one of the following criteria:
?Women of child-bearing potential must commit to use a double barrier method of contraception during the entire study, including the screening period, according to the following algorithm: [intrauterine device or hormonal contraception] plus [condom or diaphragm or spermicidal]. Women using oral contraception must also have done so for 3 months prior to the randomization (Visit 3).
?To be considered not of child-bearing potential, women must be post-menopausal for at least 2 years or surgically sterile.

7.3.2 Exclusion criteria related to background therapy and rescue medication

•Patients with contraindications for paracetamol treatment, e.g., chronic alcohol consumption (e.g., alcoholic drinks every day for male: =3; for female =2), ALAT and/or ASAT >3 x ULN, hepatocellular insufficiency (Child Pugh =9), Morbus Meulengracht (Gilbert-Syndrom; increased bilirubin due to increased unconjugated / indirect bilirubin, poor nutritional status;

•Use of the following drugs within 5-times the half-life prior to start with the baseline pain intensity assessment (Visit 1 or 2) before the randomization vis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified