Maintenance of Efficacy.

Pfizer

Status and phase: Withdrawn; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Esreboxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796601

2008-006760-10 (EudraCT Number)

A6061054

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Esreboxetine

Experimental group

Treatment:

Drug: Esreboxetine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo