Health Condition 1: M792- Neuralgia and neuritis, unspecified
Conditions
Interventions
Intervention1: FDC of Pregabalin 75 mg plus Nortriptyline 10 mg Tablets: Patients will be advised to take one tablet once a day orally every night at bedtime for 90 days.
Control Intervention1: Not Ap
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 45Ã?±5 and Day 90Ã?±5. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSurender Kumar Arora
Clinwave Research Pvt. Ltd.
Outcome results
None listed