A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia

Pfizer1 site in 1 country1,129 target enrollmentDecember 2007

ConditionsFibromyalgia

Interventions[S,S]-Reboxetine Placebo

Drugs[S,S]-Reboxetine Placebo

Overview

Phase: Phase 3
Intervention: [S,S]-Reboxetine
Conditions: Fibromyalgia
Sponsor: Pfizer
Enrollment: 1129
Locations: 1
Primary Endpoint: Change from baseline in the endpoint mean pain score
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

May 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female of any race, at least 18 years of age
•Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria

•Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
•Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
•A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
•History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features