Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

Phase 3

Terminated

• Conditions: Fibromyalgia
• Interventions: Drug: [S,S]-Reboxetine

• Registration Number: NCT00754221
• Lead Sponsor: Pfizer

Brief Summary

This is a study to investigate the long-term safety and effectiveness \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-17
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Disposition First Submitted: 2011-06-07
• Status Verified: 2019-12
• Disposition First Submitted QC: 2019-12-15
• Last Update Submitted: 2019-12-15
• Disposition First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 390

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)
• Completed preceding double-blind randomized, controlled trial

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	[S,S]-Reboxetine	-

Primary Outcome Measures

Name	Time	Method
Vital Signs	66 weeks
12-Lead ECG	66 weeks
Hematology & Biochemistry Laboratory Parameters	66 weeks
Adverse Events	66 weeks

Secondary Outcome Measures

Name	Time	Method
Short-Form 36 Health Survey	66 weeks
Sheehan Disability Scale	66 weeks
Pain Visual Analogue Scale	66 weeks
Multidimensional Assessment of Fatigue	66 weeks
Fibromyalgia Impact Questionaire	66 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Quebec, Canada