Clinical to assess the efficacy of ubidecarenone in patients diagnosed with fibromyalgia

Active, not recruiting

Conditions: Fibromyalgia
MedDRA version: 14.1Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-005982-18-ES

Lead Sponsor: Mónica Saldaña Valderas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Male and female between 18 and 65 years of age
Patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.- Patients diagnosed with rheumatologic diseases: rheumatoid artritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erytematosus, crystalline arthritis or osteoarthrosis.
2.- Severe systemic diseases, including cardiopulmonary, neurologic, renal or infectious diseases or any other condition that may affect the study
3.- Patients with severe mental disorders (psychotic, depressive or maniac disorders, suicide attempt, toxic abuse, and/or any psychical or physical disorders
4.- Patients receiving Coenzyme Q10, antidepressants, statins or tramadol
4.- Patients with pain due to other chronic diseases
5.- Pregnant and breastfeeding women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of coenzyme Q10 versus placebo in patients diagnosed with fibromyalgia in terms of clinical response measured by means of the Fibromyalgia Impact Questionnaire (FIQ);Secondary Objective: To compare the efficacy of coenzyme Q10 versus placebo in terms of clinical response measured by means of the Visual Analogue Scale (VAS)<br>To assess the safety of coenzyme Q10 administered orally;Primary end point(s): Differences between Fibromyalgia Impact Questionnaire (FIQ) scores at week 12 and baseline;Timepoint(s) of evaluation of this end point: week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Differences between Visual Analogue Scale (VAS) at week 12 and baseline<br>Plasmatic and intracellular level of coenzyme Q10 and malondialdehyde at baseline and at week 12<br>Use of any pharmacologic agent to treat pain<br>Use of alternative therapies <br>Adverse events;Timepoint(s) of evaluation of this end point: Week 12