A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

Pfizer246 enrolled

Overview

The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

246

Conditions

Pain

Interventions

[S,S]-ReboxetineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites). * At screening and randomization, patients must have a score of \>/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ). Exclusion Criteria: * Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia. * Patients with severe hepatic impairment.

Locations (61)

Outcomes

Primary Outcomes

Weekly Average Pain Score from the Daily Pain Diary.

Secondary Outcomes

Fibromyalgia Impact Questionnaire (FIQ) Total Score

Patient Global Impression of Change

Short-Form 36 Health Survey (SF 36)

Sheehan Disability Scale

Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)

Quality of Sleep Score from the Daily Sleep Diary

Multidimensional Assessment of Fatigue (MAF)

Hospital Anxiety and Depression Scales (HADS)

Short-Form McGill Pain Questionnaire (SF-MPQ)

Fibromyalgia Health Assessment Questionnaire (F-HAQ)

Safety and Tolerability

Exposure Response Relationship Between Daily Dose and Daily Pain Score

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Chandler, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Auburn, California, United States

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Orangevale, California, United States

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Pismo Beach, California, United States

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Walnut Creek, California, United States

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Newark, Delaware, United States

...and 51 more locations