An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country106 target enrollmentJuly 2009

ConditionsFibromyalgia

Interventionspregabalin (Lyrica)

Drugspregabalin (Lyrica)

Overview

Phase: Phase 3
Intervention: pregabalin (Lyrica)
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 106
Locations: 1
Primary Endpoint: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

February 2011

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 A0081208, 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 A0081208; which was determined to be related to the study medication by the investigator or the sponsor.

Arms & Interventions

pregabalin (Lyrica)

Intervention: pregabalin (Lyrica)

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame: Up to 53 weeks

Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

Secondary Outcomes

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint(Baseline, Week 52 or Study Discontinuation)
Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint(Week 52 or Study Discontinuation)
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint(Baseline, Week 52 or Study Discontinuation)
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint(Baseline, Week 52 or Study Discontinuation)