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| 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 |
| 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 |
|---|---|
| Interactive Voice Response System |
Other: IVRS
Telephone based system
|
| Personal Digital Assisstant |
Other: PDA
Electronic Hand Held diary
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| 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 |
