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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00819624 |
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 |
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Fibromyalgia |
Other: IVRS Other: PDA |
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 |
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 |
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Interactive Voice Response System |
Other: IVRS
Telephone based system
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Personal Digital Assisstant |
Other: PDA
Electronic Hand Held diary
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9001393 |
Study First Received: | January 7, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00819624 History of Changes |
Health Authority: | United States: Institutional Review Board |
fibromyalgia methodology pain sleep fatigue |
Muscular Diseases Fatigue Neuromuscular Diseases Musculoskeletal Diseases |
Myofascial Pain Syndromes Fibromyalgia Pain Rheumatic Diseases |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |