This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 3M7
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
        • Pfizer Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3K 2A7
        • Pfizer Investigational Site
    • Quebec
      • Drummondville, Quebec, Canada, J2B 7T1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
      • Pointe Claire, Quebec, Canada, H9R 3J1
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Pfizer Investigational Site
  • Denmark
      • Frederiksberg, Denmark, 2000
        • Pfizer Investigational Site
      • Svendborg, Denmark, 5700
        • Pfizer Investigational Site
  • France
      • Clermont Ferrand Cedex 1, France, 63003
        • Pfizer Investigational Site
      • Paris Cedex 04, France, 75181
        • Pfizer Investigational Site
      • Saint Priest En Jarez, France, 42270
        • Pfizer Investigational Site
    • Cedex
      • Lille, Cedex, France, 59037
        • Pfizer Investigational Site
    • Cedex 5
      • Montpellier, Cedex 5, France, 34295
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Berlin, Germany, 14109
        • Pfizer Investigational Site
      • Mannheim, Germany, 68161
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
  • India
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452001
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 001
        • Pfizer Investigational Site
      • Ludhiana, Punjab, India, 141 008
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 014
        • Pfizer Investigational Site
  • Italy
      • Bari, Italy, 79124
        • Pfizer Investigational Site
      • Benevento, Italy, 82100
        • Pfizer Investigational Site
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Chieti Scalo, Italy, 66013
        • Pfizer Investigational Site
      • Pisa, Italy
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 143-914
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 133-792
        • Pfizer Investigational Site
    • Kyeongki-do
      • Suwon-si, Kyeongki-do, Korea, Republic of, 442-712
        • Pfizer Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Pfizer Investigational Site
      • Den Helder, Netherlands, 1782 GZ
        • Pfizer Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Pfizer Investigational Site
      • Zwolle, Netherlands, 8011 JW
        • Pfizer Investigational Site
  • Portugal
      • Lisbon, Portugal, 1700-360
        • Pfizer Investigational Site
  • Sweden
      • Linkoping, Sweden, 581 85
        • Pfizer Investigational Site
      • Molndal, Sweden, 431 37
        • Pfizer Investigational Site
      • Orebro, Sweden, 701 85
        • Pfizer Investigational Site
      • Stockholm, Sweden, SE-112 81
        • Pfizer Investigational Site
  • Switzerland
      • Zurich, Switzerland, 8091
        • Pfizer Investigational Site
      • Zürich, Switzerland, 8063
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, WC1X 8LD
        • Pfizer Investigational Site
      • Poole, United Kingdom, BH12 2JB
        • Pfizer Investigational Site
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M6 8HD
        • Pfizer Investigational Site
    • Renfrewshire
      • Greenock, Renfrewshire, United Kingdom, PA16 0XN
        • Pfizer Investigational Site
    • Tyne And Wear
      • North Shields, Tyne And Wear, United Kingdom, NE29 8NH
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

  • Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Pregabalin
150 to 600mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Time Frame: Week 4
Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Week 4
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
Time Frame: Week 12 (end of treatment)
Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.
Week 12 (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe