Fibromyalgia Clinical Trial
Official title:
Quetiapine Compared With Placebo in the Management of Fibromyalgia
Verified date | July 2014 |
Source | East Tennessee State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Is quetiapine more effective than other medications in the treatment of fibromyalgia.
Status | Completed |
Enrollment | 42 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Age 18 to 60, inclusive - Females of childbearing potential using reliable method of contraception AND negative urine pregnancy test. - Widespread pain present for at least 3 months - Widespread encompassing both sides of the body, as well as above and below the waist - Pain in at least 11 of 18 tender points as determined by a physician Exclusion Criteria : - Pregnant or breastfeeding - Use of any of the following in the 14 days prior to enrollment: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, saquinavir phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids. - Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrollment - Substance or alcohol dependence at enrollment (except in full or recovery, and except nicotine or caffeine dependence) - Abuse of any of the following within 4 weeks of enrollment: opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen - Medical conditions that would affect study treatment - Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by investigator - Involvement in the planning and conduct of the study - Previous enrollment or randomization of treatment in the present study - Participation in another drug trial within 4 weeks prior to enrollment in this study or longer - Admitted to hospital for Diabetes Mellitus (DM) related illness in past 12 weeks - Not under physician's care for DM - Physician responsible for your DM care has indicated you DM is uncontrolled - Physician responsible for your DM care has not approved your participation in the study - Have not been on the same dose of DM medicine and/or diet for the 4 weeks prior to starting the study - For thiazolidinediones (glitazones) this period should not be less than 8 weeks - Taking insulin whose daily does on one occasion in the past 4 weeks has been more than 10% above or below your mean dose in the preceding 4 weeks - A low white blood cell count |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | East Tennessee State University | Johnson City | Tennessee |
Lead Sponsor | Collaborator |
---|---|
East Tennessee State University | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia Impact Questionnaire | At 25 weeks | Yes |
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