Condition category
Musculoskeletal Diseases
Date applied
21/09/2006
Date assigned
05/10/2006
Last edited
05/10/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.institutferran.es/investigacion.htm

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

http://www.fundacionfatiga.org

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

Publication citations

Additional files

Editorial Notes