Condition category
Musculoskeletal Diseases
Date applied
16/10/2005
Date assigned
07/11/2005
Last edited
21/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ferran J Garcia-Fructuoso

ORCID ID

Contact details

Paseo Manuel Girona
33
Clinica CIMA
Barcelona
08034
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BP3/2005

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

A prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Fibromyalgia

Intervention

1. Moxonidine 0.2 mg/12 hours
2. Placebo/12 hours

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 24 weeks.

Secondary outcome measures

1. Fibromyalgia Impact Questionnaire (FIQ)
2. The tender point score
3. The Hamilton Anxiety and Depression Scale (HADS)

Overall trial start date

01/12/2005

Overall trial end date

30/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

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

Recruitment start date

01/12/2005

Recruitment end date

30/08/2006

Locations

Countries of recruitment

Spain

Trial participating centre

Paseo Manuel Girona, 33
Barcelona
08034
Spain

Sponsor information

Organisation

Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)

Sponsor details

Joan Guell
184 Dp. 27
Barcelona
08028
Spain
info@fundacionfatiga.org

Sponsor type

Charity

Website

http://www.fundacionfatiga.org

Funders

Funder type

Charity

Funder name

Foundation for Fibromyalgia 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