EUCTR2013-004427-37-IT进行中（未招募）不适用
Multicentre, randomised, double-blind, dose titration design in patients with Duchenne muscular dystrophy to evaluate the efficacy and the tolerability of the combinations of Ibuprofen (200 mg bid) and Isosorbide Dinitrate (20 mg, 40 mg, 60 mg, 80 mg) - ESPP001
PARENT PROJECT ONLUS0 个研究点目标入组 188 人开始时间: 2014年9月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. 1.Patient written informed assent and parents/guardians written informed consent: provision of consent to participate in the study as shown by the signature on the Volunteer Consent Form after verbal and written information
- •2.Confirmed diagnosis of Duchenne muscular dystrophy (muscle biopsy, genetic and biochemical analysis)
- •3.Age =10 years and < 18 years
- •4.Patients non-ambulant (at least 1 year in a wheelchair) within the last 6 years
- •5.Patients who receive the standard of care for Duchenne muscular dystrophy as recommended by the Duchenne muscular dystrophy care recommendations
- •6.Patients on chronic glucocorticosteroid treatment: dosage must be stable for at least 6 months prior to the admission to the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 188
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any acute co-morbid condition interfering with the well-being of the patient within 7 days of enrolment (including bacterial infections, viral infectious processes, food poisoning, temperature > 37° C). Patients will be excluded from enrolment until the infection had been appropriately treated and resolved;
- •2. any gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhoea, gastrointestinal surgery);
- •3. a left ventricular ejection fraction (EF) of < 30%;
- •4. forced vital capacity (FVC) < 40% of predicted;
- •5. history of recurrent headache;
- •6. history or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the responsible physician, contraindicates their participation;
- •7. inability to take tablets, as assessed by the Investigator by the end of the screening period;
- •8. previous or ongoing medical conditions, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow up will be correctly completed or impair the assessment of study results, in the judgment of the Investigator;
- •9. weight of less than 13 kilograms;
- •10. participation in any other investigational drug or therapy study within the previous 6 months.
研究者
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