Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ferran J García-Fructuoso
ORCID ID
Contact details
Paseo Manuel Girona
33
Servicio de Reumatología
Clínica CIMA
Barcelona
08034
Spain
ferran.garcia@cimaclinic.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BP12/2006
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
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.
Study design
A prospective double-blind, randomised, single-center, placebo-controlled, parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Fibromyalgia (FM)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Tianeptine (moxonidine)
Primary outcome measures
The primary outcome was improvement in the pain score (10 cm Visual Analog Scale [VAS]) at 24 weeks and Fibromyalgia Impact Qiestionnnaire (FIQ) score.
Secondary outcome measures
1. The tender point score
2. The Hamilton Depression Anxiety inventory (HAD)
3. Short Form (SF-36) health survey.
Overall trial start date
01/01/2007
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged from 40 to 50 years, both genders
2. Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
01/01/2007
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Paseo Manuel Girona, 33
Barcelona
08034
Spain
Sponsor information
Organisation
Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica (Spain)
Sponsor details
c/o Joan Güell
184 Local 27
Barcelona
08028
Spain
info@fundacionfatiga.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Foundation for Fibromialgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary