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

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Pregabalin

• Registration Number: NCT00346034
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-28
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-29
• Study Start: 2006-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-02-12
• Results First Submitted QC: 2009-02-12
• Results First Posted: 2009-03-13
• Status Verified: 2018-11
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Poole, United Kingdom