A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain
1 other identifier
interventional
112
1 country
6
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2004
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedJanuary 22, 2021
April 1, 2011
March 3, 2008
January 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)
Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean pain scores
Weeks 1 and 2 and end of treatment
Secondary Outcomes (7)
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
End of treatment
Adverse events and laboratory value changes
Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean sleep interference score
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
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
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (none)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pfizer Investigational Site
Bangalore, Karnataka, 560054, India
Pfizer Investigational Site
Bangalore, Karnataka / India, 560 034, India
Pfizer Investigational Site
Mumbai, Maharashtra, 400 012, India
Pfizer Investigational Site
Maharashtra, Mumbai, 400 007, India
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 004, India
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 013, India
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2008
First Posted
March 10, 2008
Study Start
November 1, 2004
Study Completion
March 1, 2005
Last Updated
January 22, 2021
Record last verified: 2011-04