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临床试验/EUCTR2010-021397-12-BE
EUCTR2010-021397-12-BE进行中（未招募）1 期

An explorative, randomized, placebo-controlled, double-blind, parallel-group trial, to evaluate the pharmacodynamic effect of M0003 on reflux parameters in subjects with gastroesophageal reflux disease and with persistent symptoms despite taking a stable dose of proton pump inhibitors.

Shire-Movetis NV0 个研究点目标入组 100 人开始时间: 2010年9月2日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
100
研究概览入排标准研究者记录与标识符相似试验

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
All

入选标准

  • •Subjects who meet all of the following criteria are eligible for this trial:
  • •1. Written ICF signed voluntarily before the first trial-related activity.
  • •2. Aged between 18 and 70 years, extremes included.
  • •3. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation)
  • •during the last 6 months (as assessed by anamnesis/medical history).
  • •4. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
  • •5. Subjects with heartburn and/or regurgitation, with at least one of these symptoms of moderate severity or worse, and at a minimum average frequency of three days a week during the two-week run-in period (determined by completion of a daily diary).
  • •6. A minimum of 25 liquid-containing reflux events over 24 h (pH/MII monitoring).
  • •7. BMI < 35.
  • •8. If the subject is a woman of childbearing potential, she
  • •a. must have a negative urine pregnancy test at screening and before the start of
  • •treatment (minimum ß-Human Chorionic Gonadotropin [HCG] sensitivity of 25 mIU/ml), and
  • •b. must agree to either use an effective form of birth control (i.e., stabilized on oral
  • •contraceptives for at least 1 month or using implanted, transdermal or injected
  • •contraceptive hormones, an intra-uterine device, or continuous abstinence from
  • •heterosexual sexual contact), or a combination of a barrier method and a spermicidal agent (i.e., cervical cap and spermicidal agent, condom and spermicidal agent, or diaphragm and spermicidal agent), until 30 days after the end of treatment, or until the onset of menses (last day of menses to be documented at screening, baseline visit and visit 6).
  • •9. Endoscopy within the last 5 years prior to randomisation, negative for grade C & D
  • •oesophagitis.
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Subjects meeting one or more of the following criteria cannot be selected:
  • •1. History of cardiac arrhythmias, uncontrolled bronchospastic disease, cardiovascular
  • •disease (e.g., ischemic heart disease or cerebrovascular accident), thyrotoxicosis.
  • •2. Subjects with a family history of sudden death or a congenital QT syndrome.
  • •3. Presence of prolonged QTc (Bazett and Fridericia) on ECG at screening (QTc = 450
  • •msec for males and QTc = 470 msec for females).
  • •4. Subjects with a documented history of long segment (>3 cm) Barrett’s oesophagus.
  • •5. Subjects with documented or suspected large (> 3 cm) hiatus hernia.
  • •6. Subjects with fundoplication, endoscopic anti-reflux procedure or major prior GI
  • •7. Subjects with clinically significant abnormalities as judged by the investigator at
  • •screening physical examination, or in blood haematology and biochemistry tests
  • •performed at screening.
  • •8. Subjects with a structural abnormality or structural disease condition of the GI tract.
  • •9. Severe oesophageal motility disorders (e.g., scleroderma, achalasia, nutcracker
  • •oesophagus).
  • •10. Subjects who suffer from frequent vomiting (>1/week, as assessed during
  • •anamnesis).
  • •11. Current diagnosis of co-existing psychiatric disease (including alcohol or drug
  • •abuse); controlled depression and anxiety are allowed, when treated with at most
  • •one drug, at a stable dose.
  • •12. Subjects suffering from severe and/or uncontrolled endocrine (e.g., insulindependent diabetes mellitus, hypopituitarism, hypothyroidism, hypercalcaemia,
  • •pseudohypopara-thyroidism), metabolic (e.g., porphyria, hypokalaemia, amyloidal
  • •neuropathy) and neurologic diseases (e.g., Parkinson’s disease, multiple sclerosis,
  • •meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy, spinal cord injury, Chagas’ disease, major depression). Endocrine and
  • •metabolic disorders controlled by appropriate medical therapy will not be excluded,
  • •except for insulin-dependent diabetes mellitus.
  • •13. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease,
  • •neurologic, cancer or AIDS.
  • •14. Alarm symptoms suggestive of malignancies or organic disease such as: obstructive dysphagia, odynophagia, GI bleeding, blood in stool or anaemia, weight loss; unless investigated and found to be negative.
  • •15. Impaired renal function, i.e., serum creatinine concentration >2 mg/dl (>180 µmol/l).
  • •16. Use of prohibited co-medication less than 7 days before the start of the 2-week runin period (baseline symptom assessment).
  • •17. Any condition that, in the opinion of the Investigator(s), would complicate or
  • •compromise the trial (e.g., human immunodeficiency virus [HIV] infection,
  • •gastroduodenal ulcer) or the well-being of the subject, or evidence of any clinically
  • •relevant pathology that could interfere with trial results or put subject safety at risk.
  • •18. Participation in an investigational drug trial in 30 days prior to enrolment.
  • •19. Breast-feeding subjects.

研究者

发起方
Shire-Movetis NV

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