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

An Open Label, Prospective, Non-comparative, Multicentric, Single Arm, Active Post Marketing Surveillance Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Epalrestat 150 mg + Pregabalin 150 mg Bilayered Sustained Release Tablets in Adult Patients for the treatment of pain due to Diabetic Peripheral Neuropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/09/027557

Enrollment

200

Registered

2020-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G909- Disorder of the autonomic nervoussystem, unspecified

Interventions

Intervention1: FDC of Epalrestat 150 mg plus Pregabalin 150 mg Tablets: Diagnosed with pain due to diabetic peripheral neuropathy and who require treatment with FDC of Epalrestat 150 mg + Pregabalin 1

Eligibility

Inclusion criteria

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

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.

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 medicationTimepoint: 3 Months	—

Secondary

Measure	Time frame
Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Gaurav Rajauria

Universal Healthcare Research Solutions

gauravrajauria1995@gmail.com8209179682

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026