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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

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ClinicalTrials.gov Identifier: NCT00819624
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Pfizer

January 7, 2009
January 9, 2009
February 15, 2010
January 2009
March 2009   (Final data collection date for primary outcome measure)
  • Daily questions about pain asked using a telephone based system and a hand held diary [ Time Frame: 4 weeks ]
  • Daily questions about sleep asked using a telephone based system and a hand held diary [ Time Frame: 4 weeks ]
  • Daily questions about fatigue asked hand held electronic diary [ Time Frame: 2 weeks ]
  • Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00819624 on ClinicalTrials.gov Archive Site
Questionaires about sleep, mood and fibromyalgia severity [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Fibromyalgia
  • Other: Interactive Voice Response System (IVRS)
    Telephone based system
  • Other: Personal Digital Assisstant (PDA)
    Electronic Hand Held diary
  • Interactive Voice Response System
    Intervention: Other: Interactive Voice Response System (IVRS)
  • Personal Digital Assisstant
    Intervention: Other: Personal Digital Assisstant (PDA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
150
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fibromyalgia using ACR diagnosis

Exclusion Criteria:

  • Other confounding disease including other inflammatory disease, pain and depression
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00819624
A9001393
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP