|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | 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 |
|---|---|
| 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
|
| 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
|
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| 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 |
More Information
| 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 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines; Spain: Ministry of Health and Consumption; European Union: European Medicines Agency |
|
fibromyalgia quetiapine amitriptyline |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Neuromuscular Diseases Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Analgesics Antidepressive Agents Tranquilizing Agents |
Myofascial Pain Syndromes Fibromyalgia Nervous System Diseases Central Nervous System Depressants Rheumatic Diseases Antipsychotic Agents Pharmacologic Actions Antidepressive Agents, Tricyclic Quetiapine Muscular Diseases Analgesics, Non-Narcotic Amitriptyline Peripheral Nervous System Agents Central Nervous System Agents |