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

Not Applicable

Not yet recruiting

• Conditions: Neuralgia and neuritis, unspecified,

• Registration Number: CTRI/2020/09/027603
• Lead Sponsor: Aeon Formulations Pvt Ltd

Brief Summary

This trial is 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.

All the patients being prescribed the medication will be enrolled in the study. As this is an active post-marketing surveillance study to evaluate the safety, tolerability and efficacy of the drug manufactured by Aeon Formulations Pvt. Ltd, free samples will be given to all the patients to ensure that the patients do not change the test product being used. Follow up visits will be done on day 45±7 and day 90±7 (Final Visit) of treatment to assess safety, tolerability and efficacy

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-09
• Study Start: 2020-08-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

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

• Patients with known hypersensitivity to Pregabalin / Nortriptyline.
• Females of childbearing age not using effective contraception/nursing & pregnant females.
• Patients predisposed to Thrombocytopenia / liver dysfunction / renal impairment.
• 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.	3 Months

Secondary Outcome Measures

Name	Time	Method
Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.	3 Months

Trial Locations

Locations (1)

Maharaja Agrasen Superspecialty Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Maharaja Agrasen Superspecialty Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr PK Sharma

Principal investigator

9983995050

doctorpksharma.mah@gmail.com