Pregabalin In Adolescent Patients With Fibromyalgia

Phase 4

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: pregabalin

• Registration Number: NCT01020526
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Study Start: 2010-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-05
• Results First Submitted: 2016-05-24
• Results First Submitted QC: 2016-05-24
• Results First Posted: 2016-07-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregabalin	pregabalin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Numeric Rating Scale by Week	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.

Trial Locations

Locations (25)

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Apex Research Institute; 🇺🇸 Santa Ana, California, United States

Florida Medical Center & Research; 🇺🇸 Miami, Florida, United States

Harmony Clinical Research, Incorporated; 🇺🇸 North Miami Beach, Florida, United States

Rheumatology Associates of Central Florida, PA; 🇺🇸 Orlando, Florida, United States

Medical Research & Health Education Foundation, Inc.; 🇺🇸 Columbus, Georgia, United States

Kosair Charities Pediatric Clinical Research Unit; 🇺🇸 Louisville, Kentucky, United States

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University Pediatric Rheumatology of Kentucky, LLC; 🇺🇸 Louisville, Kentucky, United States

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