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Study to assess the safety of combination of Pregabalin 75 mg and Nortriptyline 10 mg Tablets available in market.

Not Applicable
Completed
Conditions
Neuralgia and neuritis, unspecified,
Registration Number
CTRI/2021/09/036458
Lead Sponsor
Synokem Pharmaceuticals Ltd
Brief Summary

Thistrial is an open label, prospective, multicentric, single arm, active postmarketing surveillance study to evaluate the safety and efficacy of FDC of Pregabalin 75 mg plusNortriptyline 10 mg Tablets in adult patients for the treatment of neuropathic pain.

 All the patientsbeing prescribed the medication will be enrolled in the study. Patients will beadvised to take one tablet once a day orally every night at bedtime for 90days. Follow up visits will be done on day 45±5 and day 90±5 (Final Visit) oftreatment to assess safety and efficacy.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
200
Inclusion Criteria

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
  • Patients with known hypersensitivity to Pregabalin / Nortriptyline.
  • Females of child bearing 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
NameTimeMethod
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.At Day 45±5 and Day 90±5.
Secondary Outcome Measures
NameTimeMethod
Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.At Day 1, Day 45 and Day 90
Consumption of rescue medication (number of other analgesic tablets consumed).At Day 45 and Day 90
Overall safety and efficacy of the study medication at the end of the study.At Day 90

Trial Locations

Locations (6)

Ananta Multispeciality Hospital

🇮🇳

Ahmadabad, GUJARAT, India

Anu Hospitals

🇮🇳

Krishna, ANDHRA PRADESH, India

Down Town Hospital

🇮🇳

Kamrup, ASSAM, India

Gandhi Medical College and Hospital

🇮🇳

Hyderabad, TELANGANA, India

GSVM Medical College

🇮🇳

Nagar, UTTAR PRADESH, India

Pushpanjali Hospital and Research Centre Pvt. Ltd.

🇮🇳

Agra, UTTAR PRADESH, India

Ananta Multispeciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Prajapati Vipulkumar Bachubhai
Principal investigator
9909912551
prajapativipul1983@gmail.com

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