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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00819624

Purpose

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.

Condition	Intervention
Fibromyalgia	Other: IVRS Other: PDA

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment
Official Title:	A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients

Further study details as provided by Pfizer:

Primary Outcome Measures:

Daily questions about pain asked using a telephone based system and a hand held diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Daily questions about sleep asked using a telephone based system and a hand held diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Daily questions about fatigue asked hand held electronic diary [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Questionnaires about sleep, mood and fibromyalgia severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Interactive Voice Response System	Other: IVRS Telephone based system
Personal Digital Assisstant	Other: PDA Electronic Hand Held diary

Detailed Description:

This is a non-drug methodology study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Fibromyalgia using ACR diagnosis

Exclusion Criteria:

Other confounding disease including other inflammatory disease, pain and depression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819624

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9001393
Study First Received:	January 7, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00819624
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

fibromyalgia, methodology, pain, sleep, fatigue

Study placed in the following topic categories:

Muscular Diseases
Fatigue
Neuromuscular Diseases
Musculoskeletal Diseases

Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009