Active PMS study to Evaluate the Safety, Tolerability and Efficacy of FDC of Epalrestat 150 mg plus Pregabalin 150 mg Bilayered Sustained Release Tablets in Adult Patients for the treatment of pain due to Diabetic Peripheral Neuropathy
Phase 4
- Conditions
- Health Condition 1: G909- Disorder of the autonomic nervoussystem, unspecified
- Registration Number
- CTRI/2020/09/027557
- Lead Sponsor
- Aeon Formulations Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adults male or female patients aged 18 to 65 years (both inclusive), diagnosed with pain due to diabetic peripheral neuropathy and who require treatment with FDC of Epalrestat 150 mg + Pregabalin 150 mg Tablets as part of their routine treatment regimen
Exclusion Criteria
1.Patients with known hypersensitivity to Pregabalin / Epalrestat.
2.Females of childbearing age not using effective contraception/nursing & pregnant females.
3.Patients predisposed to Thrombocytopenia / liver dysfunction / renal impairment.
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 medicationTimepoint: 3 Months
- Secondary Outcome Measures
Name Time Method Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.Timepoint: 3 months