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| Sponsor: | Universidad de Granada |
|---|---|
| Collaborators: |
AstraZeneca Hospital Clinico Universitario San Cecilio |
| Information provided by: | Universidad de Granada |
| ClinicalTrials.gov Identifier: | NCT00766350 |
Purpose
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 |
|---|---|---|
|
Fibromyalgia |
Drug: amitriptyline Drug: quetiapine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 90 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: amitriptyline |
Drug: amitriptyline
initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks
Other Name: Tryptizol
|
| Experimental: quetiapine |
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
Other Name: Seroquel XR
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Hospital Clinico Universitario San Cecilio | |
| Granada, Spain, 18012 | |
| Principal Investigator: | Elena P Calandre, MD | Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio |
More Information
| Responsible Party: | Elena Pita Calandre, Clinical Pharmacology Department of the Hospital Universitario San Cecilio |
| ClinicalTrials.gov Identifier: | NCT00766350 History of Changes |
| Other Study ID Numbers: | D1443C00024 |
| Study First Received: | October 1, 2008 |
| Last Updated: | January 10, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines; Spain: Ministry of Health and Consumption; European Union: European Medicines Agency |
|
fibromyalgia quetiapine amitriptyline |
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Amitriptyline Amitriptyline, perphenazine drug combination Quetiapine Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |