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

Phase 3
Completed
Conditions
Neuralgia
Interventions
Registration Number
NCT00631943
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
112
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Pregabalin (Lyrica)-
Primary Outcome Measures
NameTimeMethod
Change from baseline in weekly mean pain scoresWeeks 1 and 2 and end of treatment
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)Weeks 1 and 2 and end of treatment
Secondary Outcome Measures
NameTimeMethod
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-FormEnd 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-MPQWeeks 1 and 2 and end of treatment
Change from baseline in Clinical Global Impression of Change (CGIC)Weeks 1 and 2 and end of treatment
Change from baseline in Patient Global Impression of Change (PGIC)Weeks 1 and 2 and end of treatment
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scoresEnd of treatment
Adverse events and laboratory value changesWeeks 1 and 2 and end of treatment
Change from baseline in weekly mean sleep interference scoreWeeks 1 and 2 and end of treatment

Trial Locations

Locations (1)

Pfizer Investigational Site

🇮🇳

Chennai, Tamil, Nadu, India

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