Moxonidine for the treatment of fibromyalgia: a prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
| ISRCTN | ISRCTN70535562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70535562 |
| Protocol serial number | BP3/2005 |
| Sponsor | Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain) |
| Funder | Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain) |
- Submission date
- 16/10/2005
- Registration date
- 07/11/2005
- Last edited
- 21/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ferran J Garcia-Fructuoso
Scientific
Scientific
Paseo Manuel Girona, 33
Clinica CIMA
Barcelona
08034
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | 1. Moxonidine 0.2 mg/12 hours 2. Placebo/12 hours |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 24 weeks. |
| Key secondary outcome measure(s) |
1. Fibromyalgia Impact Questionnaire (FIQ) |
| Completion date | 30/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 30/08/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
Paseo Manuel Girona, 33
Barcelona
08034
Spain
08034
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
