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NCT00631943 Clinical Trial

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

Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00631943
Other study ID # A0081068
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2004
Est. completion date March 2005

Study information
Verified date April 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
India Pfizer Investigational Site Bangalore Karnataka / India
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Chennai Tamil Nadu
India Pfizer Investigational Site Chennai Tamil, Nadu
India Pfizer Investigational Site Maharashtra Mumbai
India Pfizer Investigational Site Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

India, 

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