A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients

NCT ID: NCT00819624

Last Updated: 2010-02-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

Brief Summary

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The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Interactive Voice Response System

Group Type OTHER

Interactive Voice Response System (IVRS)

Intervention Type OTHER

Telephone based system

Personal Digital Assisstant

Group Type OTHER

Personal Digital Assisstant (PDA)

Intervention Type OTHER

Electronic Hand Held diary

Interventions

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Interactive Voice Response System (IVRS)

Telephone based system

Intervention Type OTHER

Personal Digital Assisstant (PDA)

Electronic Hand Held diary

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Fibromyalgia using ACR diagnosis

Exclusion Criteria

* Other confounding disease including other inflammatory disease, pain and depression
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Roseville, California, United States

Site Status

Pfizer Investigational Site

Baton Rouge, Louisiana, United States

Site Status

Pfizer Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

Pfizer Investigational Site

Jefferson City, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Pfizer Investigational Site

Johnson City, New York, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Johnson City, Tennessee, United States

Site Status

Pfizer Investigational Site

New Tazewell, Tennessee, United States

Site Status

Pfizer Investigational Site

Lake Jackson, Texas, United States

Site Status

Pfizer Investigational Site

Charlottesville, Virginia, United States

Site Status

Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Pfizer Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A9001393

Identifier Type: -

Identifier Source: org_study_id

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