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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country357 target enrollmentDecember 2006

ConditionsFibromyalgia

InterventionsPregabalin

DrugsPregabalin

Overview

Phase: Phase 3
Intervention: Pregabalin
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 357
Locations: 1
Primary Endpoint: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

February 2008

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: Pregabalin

Outcomes

Primary Outcomes

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.

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.