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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: [S,S]-Reboxetine
* Drug: Placebo
* Drug: [S,S]-Reboxetine
* Drug: [S,S]-Reboxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3<br> | Drug: [S,S]-Reboxetine<br>* 10 mg oral tablet once a day dosing<br>|
| Sham Comparator: 4<br> | Drug: Placebo<br>* 0 mg oral tablet once a day dosing<br>|
| Experimental: 1<br> | Drug: [S,S]-Reboxetine<br>* 4 mg oral tablet once a day dosing<br>|
| Experimental: 2<br> | Drug: [S,S]-Reboxetine<br>* 8 mg oral tablet once a day dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the endpoint mean pain score |  | 14 weeks | 
| Fibromyalgia Impact Questionnaire |  | 14 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia