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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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 3, 2008
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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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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A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain

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