Fibromyalgia Clinical Trial
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
Verified date | February 2010 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 185 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Fibromyalgia using ACR diagnosis Exclusion Criteria: - Other confounding disease including other inflammatory disease, pain and depression |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
United States | Pfizer Investigational Site | Charlottesville | Virginia |
United States | Pfizer Investigational Site | Cincinnati | Ohio |
United States | Pfizer Investigational Site | Jefferson City | Missouri |
United States | Pfizer Investigational Site | Johnson City | New York |
United States | Pfizer Investigational Site | Johnson City | Tennessee |
United States | Pfizer Investigational Site | Lake Jackson | Texas |
United States | Pfizer Investigational Site | New Tazewell | Tennessee |
United States | Pfizer Investigational Site | North Dartmouth | Massachusetts |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Richmond | Virginia |
United States | Pfizer Investigational Site | Roseville | California |
United States | Pfizer Investigational Site | Spokane | Washington |
United States | Pfizer Investigational Site | St. Louis | Missouri |
United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily questions about pain asked using a telephone based system and a hand held diary | 4 weeks | No | |
Primary | Daily questions about sleep asked using a telephone based system and a hand held diary | 4 weeks | No | |
Primary | Daily questions about fatigue asked hand held electronic diary | 2 weeks | No | |
Primary | Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use | 4 weeks | No | |
Secondary | Questionaires about sleep, mood and fibromyalgia severity | 4 weeks | No |
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