A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
Primary Purpose
Neuralgia
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Pregabalin (Lyrica)
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia
Eligibility Criteria
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)
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)
Change from baseline in weekly mean pain scores
Secondary Outcome Measures
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
Adverse events and laboratory value changes
Change from baseline in weekly mean sleep interference score
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ
Change from baseline in Patient Global Impression of Change (PGIC)
Change from baseline in Clinical Global Impression of Change (CGIC)
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form
Full Information
NCT ID
NCT00631943
First Posted
March 3, 2008
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00631943
Brief Title
A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
Official Title
An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pregabalin (Lyrica)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Change from baseline in weekly mean pain scores
Time Frame
Weeks 1 and 2 and end of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
Time Frame
End of treatment
Title
Adverse events and laboratory value changes
Time Frame
Weeks 1 and 2 and end of treatment
Title
Change from baseline in weekly mean sleep interference score
Time Frame
Weeks 1 and 2 and end of treatment
Title
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
Title
Change from baseline in Patient Global Impression of Change (PGIC)
Time Frame
Weeks 1 and 2 and end of treatment
Title
Change from baseline in Clinical Global Impression of Change (CGIC)
Time Frame
Weeks 1 and 2 and end of treatment
Title
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form
Time Frame
End of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka / India
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Pfizer Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Pfizer Investigational Site
City
Maharashtra
State/Province
Mumbai
ZIP/Postal Code
400 007
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 004
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamil, Nadu
ZIP/Postal Code
600 013
Country
India
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081068&StudyName=A%20study%20to%20evaluate%20the%20efficacy%20and%20safety%20of%20Lyrica%20for%20the%20treatment%20of%20nerve%20pain
Description
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Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
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