A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

Phase 3

Completed

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

• Registration Number: NCT00612170
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-11
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Disposition First Submitted: 2011-06-07
• Status Verified: 2019-12
• Disposition First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Disposition First Posted: 2019-12-12
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1129

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)

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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: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	[S,S]-Reboxetine	-
4	Placebo	-
1	[S,S]-Reboxetine	-
2	[S,S]-Reboxetine	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the endpoint mean pain score	14 weeks
Fibromyalgia Impact Questionnaire	14 weeks

Secondary Outcome Measures

Name	Time	Method
Short Form 36	14 weeks
Pain Visual Analogue Scale	14 weeks
Patient Global Impression of Change	14 weeks
Hospital Anxiety and Depression Scale	14 weeks
Change from baseline in the endpoint mean sleep interference score	14 weeks
Multidimensional Assessment of Fatigue	14 weeks
Sheehan Disability Score	14 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Quebec, Canada