Study to assess the safety of combination of Pregabalin 75 mg and Nortriptyline 10 mg Tablets available in market.
Phase 4
Completed
- Conditions
- Health Condition 1: M792- Neuralgia and neuritis, unspecified
- Registration Number
- CTRI/2021/09/036458
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. 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.
Exclusion Criteria
1. Patients with known hypersensitivity to Pregabalin / Nortriptyline.
2. Females of child bearing age not using effective contraception / nursing & pregnant females.
3. Patients predisposed to Thrombocytopenia / liver dysfunction / renal impairment.
4. 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.Timepoint: At Day 45�±5 and Day 90�±5.
- Secondary Outcome Measures
Name Time Method Consumption of rescue medication (number of other analgesic tablets consumed).Timepoint: At Day 45 and Day 90;Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.Timepoint: At Day 1, Day 45 and Day 90;Overall safety and efficacy of the study medication at the end of the study.Timepoint: At Day 90