Post Marketing Surveillance Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets in Adult Patients for the treatment of Neuropathic Pain

An Open Label, Prospective, Non-comparative,Multicentric, Single Arm, Active Post Marketing Surveillance Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets in Adult Patients for the treatment of Neuropathic Pain.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/09/027603

Enrollment

200

Registered

2020-09-04

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: M792- Neuralgia and neuritis, unspecified

Interventions

Intervention1: Pregabalin 75 mg and Nortriptyline 10 mg Tablets: Diagnosed with neuropathic pain and who require treatment with FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets as part of their

Eligibility

Inclusion criteria

Inclusion criteria: Adults 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 and 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 childbearing 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: 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