A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.25 sites in 3 countries63 target enrollmentSeptember 2010

ConditionsFibromyalgia

Interventionspregabalin

Drugspregabalin

Overview

Phase: Phase 4
Intervention: pregabalin
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 63
Locations: 25
Primary Endpoint: Change From Baseline in Pain Numeric Rating Scale by Week
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 study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

June 2015

Last Updated

5 years ago

Study Type

Interventional

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 Study A0081180, and 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 A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Arms & Interventions

Pregabalin

Intervention: pregabalin

Outcomes

Primary Outcomes

Change From Baseline in Pain Numeric Rating Scale by Week

Time Frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit.

The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.