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: 9.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Interventions
Product Name: Ataciguat
Product Code: HMR1766
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ataciguat
CAS Number: 254-976-06-2
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 11%; • Patients with an average daily pain intensity for their neuropathic pain 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of ataciguat administered as 200 mg once daily for 28 days in comparison to placebo in reducing pain intensity in patients with chronic neuropathic pain.;Secondary Objective: • To investigate the safety and tolerability of 200 mg ataciguat once daily in comparison to placebo. • To compare the effects of ataciguat with placebo on the change of pain intensity versus baseline by using the following scales and clinical tests: ? The Visual Analog Scale Pain Relief Scale, ? The Visual Analog Scale Pain Intensity Scale, ? The Neuropathic Pain Symptom Inventory. • To evaluate the effects of ataciguat in comparison to placebo on the change in pain intensity of mechanical allodynia. • To evaluate the use of rescue medication (paracetamol) in ataciguat-treated patients in comparison to placebo-treated patients. • To assess the exposure to ataciguat. ;Primary end point(s): Primary endpoint: Change in the average daily pain intensity defined as the mean of the last 7 days of each treatment period compared to baseline. | — |
Countries
Austria, Czech Republic, Germany
Outcome results
None listed