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

Randomized, placebo-controlled and double blind clinical trial to assess the efficacy of ubidecarenone in patients diagnosed with fibromyalgia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005982-18-ES
Enrollment
Unknown
Registered
2012-10-25
Start date
2013-01-09
Completion date
Unknown
Last updated
2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia MedDRA version: 14.1 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Decorenone 50 mg capsules Product Name: Ubidecarenone Pharmaceutical Form: Hard capsule with gastro-resistant pellets INN or Proposed INN: UBIDECARENONE CAS Number: 303-98-0 Current Spons
Ubiquinone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Sponsors

Mónica Saldaña Valderas
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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) 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

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

Countries

Spain

Contacts

Public ContactMónica Saldaña

Mónica Saldaña

monica.saldana.exts@juntadeandalucia.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026