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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00819624
First received: January 7, 2009
Last updated: February 12, 2010
Last verified: February 2010
  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: Interactive Voice Response System (IVRS)
Other: Personal Digital Assisstant (PDA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


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

Enrollment: 185
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Interactive Voice Response System Other: Interactive Voice Response System (IVRS)
Telephone based system
Personal Digital Assisstant Other: Personal Digital Assisstant (PDA)
Electronic Hand Held diary

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Pfizer Investigational Site
Roseville, California, United States, 95661
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States, 65109
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, New York
Pfizer Investigational Site
Johnson City, New York, United States, 13790
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37601
Pfizer Investigational Site
New Tazewell, Tennessee, United States, 37825
United States, Texas
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99216
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00819624     History of Changes
Other Study ID Numbers: A9001393
Study First Received: January 7, 2009
Last Updated: February 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
fibromyalgia methodology pain sleep fatigue

Additional relevant MeSH terms:
Fatigue
Fibromyalgia
Myofascial Pain Syndromes
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014