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OpenTrials
Completed

NCT Number: NCT00819624

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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Roseville, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fibromyalgia using ACR diagnosis

Exclusion criteria

  • Other confounding disease including other inflammatory disease, pain and depression

Treatment and study plan

Interactive Voice Response System (IVRS)

Other

Telephone based system

Personal Digital Assisstant (PDA)

Other

Electronic Hand Held diary

Primary outcomes

  1. Daily questions about pain asked using a telephone based system and a hand held diary

    Time frame: 4 weeks

  2. Daily questions about sleep asked using a telephone based system and a hand held diary

    Time frame: 4 weeks

  3. Daily questions about fatigue asked hand held electronic diary

    Time frame: 2 weeks

  4. Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use

    Time frame: 4 weeks

Secondary outcomes

  1. Questionaires about sleep, mood and fibromyalgia severity

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2009
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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