Maintenance of Efficacy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-01

Study Completion Date

2010-11-01

Brief Summary

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The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Esreboxetine

Group Type EXPERIMENTAL

Esreboxetine

Intervention Type DRUG

Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Film coated tablets (0 mg esreboxetine), once daily for 6 months

Interventions

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Esreboxetine

Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months

Intervention Type DRUG

Placebo

Film coated tablets (0 mg esreboxetine), once daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
* Pain score greater than or equal to 4 on an 11-point NRS
* FIQ-Total score greater than or equal to 45 points

Exclusion Criteria

* Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
* Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
* Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No