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Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

Primary Purpose

Peripheral Neuropathy, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin
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 Peripheral Neuropathy

Eligibility Criteria

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

Inclusion Criteria: Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7 Exclusion Criteria: Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor non-compliant during A0081066 trial clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • 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

Mean Visual Analogue Scale (VAS) Pain Scores
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2005
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00264875
Brief Title
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
Official Title
An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (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
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
75mg BID, titrated up to 300mg according to individual response and tolerability
Primary Outcome Measure Information:
Title
Mean Visual Analogue Scale (VAS) Pain Scores
Description
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.
Time Frame
Baseline, Week 4, Week 8, Week 12, and Endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7 Exclusion Criteria: Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor non-compliant during A0081066 trial clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-1460
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Pfizer Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5235
Country
United States
Facility Name
Pfizer Investigational Site
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Pfizer Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504-5719
Country
United States
Facility Name
Pfizer Investigational Site
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Pfizer Investigational Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-7609
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-3318
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208-4234
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9036
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
San Juan
ZIP/Postal Code
00909-1711
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081095&StudyName=Open%20Label%20Safety%20And%20Efficacy%20Study%20Of%20Pregabalin%20In%20Subjects%20With%20Nerve%20Pain%20Asociated%20With%20HIV%20Neuropathy
Description
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Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

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