JPRN-UMIN000012934CompletedPhase 2
The multicenter clinical trial of the efficacy and safety of bezafibrate for mitochondrial fatty acid Beta-oxidation disorders
Shimane University School of Medicine0 sites10 target enrollmentStarted: January 24, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 3years-old to 60years-old (—)
- Sex
- All
Inclusion Criteria
- •Patient who:
- •(1) ages 3 to 60 at the time of obtaining informed consent.
- •(2) is enzymologically or genetically-proven as FAOD (any oneof CPT II, VLCAD, TFP, GA2, CPT I, MCAD, CACT) at the time of obtaining informed consent.
- •(3) weighs over 10.0kg at the time of screening test.
- •(4) has had episodes of muscular symptoms (general malaise, strong stiff shoulder or back pain, myalgia, lassitude of extremities, muscle weakness, myoglobinuria or subject-specific muscular symptoms) twice and more within 6 months or 4 times and more within 1 year prior to obtaining informed consent.
- •(5) has had the CK value which was more than double ULN at the time of attacks within 3 months prior to obtaining informed consent.
- •(6) gives written informed consent before enrolling the study.
- •The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. Subjective patients under 20-year-old should receive an adequate explanation depending on one's ability to understand, and give assent with written forms if possible.
Exclusion Criteria
- •Patient who;
- •(1) has the serum creatinine level more than 1.5 mg/dL at the time of screening test
- •(2) has a heart disease or liver damage requiring treatment
- •(3) has gallstones or a previous history of them
- •(4) is treated with HMG-CoA reductase inhibitor
- •(5) takes Bezafibrate or have a history of taking it
- •(6) is pregnant or nursing women, or expected to (wishing and planning to) become pregnant
- •(7) is considered ineligible for enrolling the study by a principal investigator or subinvestigator
Investigators
Similar Trials
Active, not recruiting
Phase 1
Multicentre clinical trial to evaluate the efficacy and safety of dexketoprofen trometamol (50 mg t.i.d.) versus ketorolac (30 mg t.i.d.) and placebo by intravenous route, as part of balanced analgesic therapy with morphine, followed by an oral dosing, in the treatment of postoperative paielective orthopedic surgery (hip arthroplasty)MedDRA version: 7.0Level: PTClassification code 10020096EUCTR2004-001373-26-ESaboratorios Menarini, S.A
Not yet recruiting
Not Applicable
Comparative clinical study of eye drops in dry eye syndromeDiseases of the eye and adnexaKCT0004516Kangbuk Samsung Medical Center60
Recruiting
Phase 2
Multicenter clinical trial to evaluate the efficacy of rituximab combination chemotherapy for children or AYAswith localized mature B-cell lymphomaJPRN-jRCTs041210104Sekimizu Masahiro100
Completed
Not Applicable
Multicentric clinical trial on the efficacy and safety of ceftriaxone and sulbactam in lower respiratory tract infectioower respiratory tract infectionInfections and InfestationsRespiratory tract infectionISRCTN51896330Venus Remedies Limited (India)105
Not yet recruiting
Phase 2
ACENT 1Patients with Sickle Cell Disease.Sickle cell disease (SCD) Foetal haemoglobin (HbF) mutated sickle cell haemoglobin (HbS)LBCTR2024015480ovo Nordisk87