Status:
COMPLETED
Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome
Lead Sponsor:
Duke University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated wheth...
Detailed Description
Introduction Despite the skepticism of some physicians over the very existence of a condition called Fibromyalgia syndrome (FMS), most agree that this is a common condition seen in pain clinics. The ...
Eligibility Criteria
Inclusion
- A diagnosis of fibromyalgia according to American College of Rheumatology criteria
- A pain score of \> 5 cm on a 0 to 10 Visual Analogue Scale
- \< 23 on the Beck Depression Inventory-II.
- 18 and 65 years of age
- Ability to give informed consent
- If patients are of child-bearing potential, an effective contraceptive was required (i.e., oral, depo-provera, or implanted contraceptives, an IUD, a diaphragm or condom with spermicide or abstinence) for at least one month prior to the Screening Visit and have a negative pregnancy test upon entry into the study.
Exclusion
- Diagnosis of systemic lupus erythematous or other connective tissue disorders (e.g., scleroderma, polymyositis, sjogren's syndrome).
- Diagnosis of myopathy, muscular dystrophy, rheumatoid arthritis, crystal induced arthritis.
- Involvement in a litigation concerning fibromyalgia or silicone breast implant disease
- Use of antidepressant medications (including MAO Inhibitors) within the previous week or previous 5 weeks for fluoxetine.
- History of allergy or hypersensitivity to NSAIDs or antidepressants.
- Treatment with an investigational drug within 30 days prior to the Screening Visit.
- Treatment with corticosteroids within 14 days prior to the Screening Visit or acupuncture treatment within 21 days prior to the Screening Visit.
- Analgesic and sedative medication doses will remain unchanged during the treatment.
- Patients on antidepressants for mood and anxiety disorders.
- Current or previous history of bipolar disorder, schizophrenia, schizoaffective disorder or major somatization disorder.
- Current diagnosis of major depression or anxiety disorder on the MINI.
- Hospitalization for psychotic episode or attempted suicide within one year of study entry.
- Current substance abuse or history of substance abuse in the previous 12 months.
- Diagnosis of uncontrolled hypothyroidism or brittle diabetes.
- History of bleeding diathesis of any etiology.
- History of chronic hepatitis or cirrhosis.
- Glaucoma
- Presence of active gastrointestinal bleeding or an active ulcer within one month prior to the Screening Visit.
- Significant cardiac, pulmonary, metabolic, renal, or hepatic disease, or history of malignancy.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00610610
Start Date
January 1 2002
End Date
December 1 2002
Last Update
June 20 2013
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107