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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00819624
First received: January 7, 2009
Last updated: February 12, 2010
Last verified: February 2010
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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
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 May 19, 2013