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ISRCTN
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ISRCTN16400909
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ClinicalTrials.gov identifier
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Public title
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Tianeptine 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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BP12/2006
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Study hypothesis
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Fibromyalgia (FM) is a common illness that affects approximately 2.5 to 13% of the general population, of which the majority (10/1) are female. FM is characterised by chronic widespread pain and 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.
Tianeptine is an antidepressant agent with a novel neurochemical profile. It increases serotonin (5-HydroxyTryptamine [5-HT]) uptake in the brain (in contrast with most antidepressant agents), promotes neuroplasticity and reduces stress-induced atrophy of neuronal dendrites. Like the Selective Serotonin Reuptake Inhibitors (SSRIs) and in contrast with most tricyclic antidepressant agents, tianeptine does not appear to be associated with adverse cognitive, psychomotor, sleep, cardiovascular or bodyweight effects and has a low propensity for abuse. This study assess the efficacy and safety of tianeptine in patients with FM.
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Ethics approval
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Comité Ético de Investigación Clínica de Clínica, International Centre of Advanced Medicine (Centro Internacional de Medicina Avanzada [CIMA]) (Barcelona, Spain) (reference number: 0036/2006CIMA), date of approval is 10th August 2006.
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Study design
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A prospective double-blind, randomised, single-center, 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 (FM)
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Participants - inclusion criteria
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1. Aged from 40 to 50 years, both genders
2. 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. Major 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. Contraindications to tianeptine
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Anticipated start date
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01/01/2007
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Anticipated end date
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01/09/2007
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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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Group one - intervention group: Three month supply of oral Tianeptine (tablets) 12.5 mg every eight hours.
Group two - control group: Identical placebo every eight 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 and Fibromyalgia Impact Qiestionnnaire (FIQ) score.
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Secondary outcome measure(s)
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1. The tender point score
2. The Hamilton Depression Anxiety inventory (HAD)
3. Short Form (SF-36) health survey.
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Sources of funding
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Foundation for Fibromialgia 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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http://www.institutferran.es/investigacion.htm
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Publications
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Contact name
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Prof
Ferran J
García-Fructuoso
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Address
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Paseo Manuel Girona, 33
Servicio de Reumatología
Clínica 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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Email
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ferran.garcia@cimaclinic.com
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Sponsor
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Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica (Spain)
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Address
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c/o Joan Güell
184 Local 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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21/09/2006
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Last edited
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05/10/2006
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Date ISRCTN assigned
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05/10/2006
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