A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain

The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Pfizer Investigational Site
    • Karnataka / India
      • Bangalore, Karnataka / India, India, 560 034
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Pfizer Investigational Site
    • Mumbai
      • Maharashtra, Mumbai, India, 400 007
        • Pfizer Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 004
        • Pfizer Investigational Site
    • Tamil, Nadu
      • Chennai, Tamil, Nadu, India, 600 013
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Peripheral neuropathic pain
  • Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
  • Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline

Exclusion criteria:

(none)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Pregabalin (Lyrica)
Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean pain scores
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
Time Frame: End of treatment
End of treatment
Adverse events and laboratory value changes
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean sleep interference score
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment
Change from baseline in Patient Global Impression of Change (PGIC)
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment
Change from baseline in Clinical Global Impression of Change (CGIC)
Time Frame: Weeks 1 and 2 and end of treatment
Weeks 1 and 2 and end of treatment
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form
Time Frame: End of treatment
End of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 3, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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