Study to assess the safety of combination of Pregabalin 75 mg and Nortriptyline 10 mg Tablets available in market.
- Conditions
- Neuralgia and neuritis, unspecified,
- Registration Number
- CTRI/2021/09/036458
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Thistrial is an open label, prospective, multicentric, single arm, active postmarketing surveillance study to evaluate the safety and efficacy of FDC of Pregabalin 75 mg plusNortriptyline 10 mg Tablets in adult patients for the treatment of neuropathic pain.
All the patientsbeing prescribed the medication will be enrolled in the study. Patients will beadvised to take one tablet once a day orally every night at bedtime for 90days. Follow up visits will be done on day 45±5 and day 90±5 (Final Visit) oftreatment to assess safety and efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Male or female patients aged 18 to 65 years (both inclusive), diagnosed with neuropathic pain and who require treatment with FDC of Pregabalin 75 mg plus Nortriptyline 10 mg Tablets as part of their routine treatment regimen.
- Patients with known hypersensitivity to Pregabalin / Nortriptyline.
- Females of child bearing age not using effective contraception / nursing & pregnant females.
- Patients predisposed to Thrombocytopenia / liver dysfunction / renal impairment.
- Patients with known history of myocardial infarction (MI) / cardiac arrhythmia.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication. At Day 45±5 and Day 90±5.
- Secondary Outcome Measures
Name Time Method Improvement in Numeric Rating Scale (NRS) from baseline to end of the study. At Day 1, Day 45 and Day 90 Consumption of rescue medication (number of other analgesic tablets consumed). At Day 45 and Day 90 Overall safety and efficacy of the study medication at the end of the study. At Day 90
Trial Locations
- Locations (6)
Ananta Multispeciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
Anu Hospitals
🇮🇳Krishna, ANDHRA PRADESH, India
Down Town Hospital
🇮🇳Kamrup, ASSAM, India
Gandhi Medical College and Hospital
🇮🇳Hyderabad, TELANGANA, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Pushpanjali Hospital and Research Centre Pvt. Ltd.
🇮🇳Agra, UTTAR PRADESH, India
Ananta Multispeciality Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Prajapati Vipulkumar BachubhaiPrincipal investigator9909912551prajapativipul1983@gmail.com