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Sponsors and Collaborators: |
Universidad de Granada AstraZeneca Hospital Clinico Universitario San Cecilio |
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Information provided by: | Universidad de Granada |
ClinicalTrials.gov Identifier: | NCT00766350 |
Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of the present study is to compare, in a controlled setting, the efficacy and the tolerability of quetiapine extended release with amitriptyline in the treatment of patients with fibromyalgia
Condition | Intervention | Phase |
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Fibromyalgia |
Drug: amitriptyline Drug: quetiapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Pilot Clinical Trial to Assess the Comparative Efficacy and Tolerability of Quetiapine XR Versus Amitriptyline for the Treatment of Patients With Fibromyalgia |
Estimated Enrollment: | 90 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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amitriptyline: Active Comparator |
Drug: amitriptyline
initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks
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quetiapine: Experimental |
Drug: quetiapine
initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elena P. Calandre, MD | +34 958023135 | epita@ugr.es |
Contact: Fernando Rico-Villademoros, MD | +34 915428826 | fernando.ricovillademoros@gmail.com |
Spain | |
Hospital Clinico Universitario San Cecilio | Recruiting |
Granada, Spain, 18012 | |
Contact: Elena P. Calandre, MD +34 958023135 epita@ugr.es | |
Contact: Fernando Rico-Villademoros, MD +34 915428826 fernando.ricovillademoros@gmail.com | |
Sub-Investigator: Piedad Morillas-Arques, MD | |
Sub-Investigator: Carmen Rodriguez-Lopez, MD | |
Sub-Investigator: Javier Hidalgo, MD | |
Sub-Investigator: Rocio Molina-Barea, MD | |
Sub-Investigator: Juan S. Vilchez |
Principal Investigator: | Elena P Calandre, MD | Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio |
Responsible Party: | Clinical Pharmacology Department of the Hospital Universitario San Cecilio ( Elena Pita Calandre ) |
Study ID Numbers: | D1443C00024, 2008-003694-41 |
Study First Received: | October 1, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00766350 |
Health Authority: | Spain: Spanish Agency of Medicines; Spain: Ministry of Health and Consumption; European Union: European Medicines Agency |
fibromyalgia quetiapine amitriptyline |
Quetiapine Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Amitriptyline Pain Rheumatic Diseases |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Antipsychotic Agents Pharmacologic Actions Antidepressive Agents, Tricyclic Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Antidepressive Agents |