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ISRCTN
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ISRCTN70535562
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ClinicalTrials.gov identifier
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Public title
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Moxonidine for the treatment of fibromyalgia: a prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
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Scientific title
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Acronym
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N/A
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Serial number at source
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BP3/2005
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Study hypothesis
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Fibromyalgia (FM) is a common illness that affects ~ 2.5% of the general population, of which the majority (9/1) are female. FM is characterized by chronic widespread pain and by sleeping problems. Patients with FM frequently have other symptoms such as headaches, nocturnal jaw tightness, morning stiffness, tingling and numbness of arms and legs, irritable bowel, urinary urgency, dryness in the mouth and eyes, cold swollen hands, anxiety and/or depression. Another characteristic of FM is tenderness at palpation in defined points at the neck and lower back areas.
Hypothesis:
Sympathetic nervous system function in fibromyalgia seems overactivated. I1-Imidazoline agonist Moxonidine decreases sympathetic nerve activity. This study assess the efficacy and safety of Moxonidine in patients with fibromyalgia.
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Ethics approval
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Not provided at time of registration
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Study design
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A prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Fibromyalgia
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Participants - inclusion criteria
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1. Ages eligible for study: 30 - 60 years
2. Genders eligible for study: both
3. Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
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Participants - exclusion criteria
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1. Psychiatric illness
2. Depression
3. Suicidal risk
4. Substance abuse
5. Pulmonary dysfunction
6. Renal impairment
7. Active cardiac disease
8. Liver disease
9. Autoimmune disease
10. Cancer
11. Sleep apnea
12. Chronic Fatigue Syndrome
13. Inflammatory bowel disease
14. Contraindication of Moxonidine
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Anticipated start date
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01/12/2005
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Anticipated end date
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30/08/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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1. Moxonidine 0.2 mg/12 hours
2. Placebo/12 hours
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Primary outcome measure(s)
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The primary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 24 weeks.
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Secondary outcome measure(s)
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1. Fibromyalgia Impact Questionnaire (FIQ)
2. The tender point score
3. The Hamilton Anxiety and Depression Scale (HADS)
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Sources of funding
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Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)
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Trial website
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Publications
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Contact name
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Dr
Ferran J
Garcia-Fructuoso
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Address
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Paseo Manuel Girona, 33
Clinica CIMA
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City/town
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Barcelona
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Zip/Postcode
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08034
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Country
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Spain
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Sponsor
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Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)
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Address
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Joan Guell
184 Dp. 27
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City/town
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Barcelona
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Zip/Postcode
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08028
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Country
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Spain
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Email
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info@fundacionfatiga.org
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Sponsor website:
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http://www.fundacionfatiga.org
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Date applied
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16/10/2005
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Last edited
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21/09/2007
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Date ISRCTN assigned
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07/11/2005
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