NL-OMON34276尚未招募2 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. - N/A
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Movetis NV
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 must have a negative urine pregnancy test at screening and before the start or treatment and must agree to either use an effective form of birth control or a combination of a barier method and a spermicidal agent until 30 days after the end of treatment, or until onset of menses.
- •9. Endoscopy within the last 5 years prior to randomisation, negative for grade C & D oesophagitis (according to the Los Angeles classification).
排除标准
- •1. History of cardiac arrhythmias, uncontrolled bronchospastic disease and controlled bronchospastic disease with symptoms, 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 surgery.
- •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, metabolic and neurologic diseases. 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 micromol/l).
- •16. Use of prohibited co-medication less than 7 days before the start of the 2-week run-in period (baseline symptom assessment).
- •17. Any condition that, in the opinion of the Investigator(s), would complicate or compromise the trial or the well-being of the subject, or evidence of any clinically relevant pathology that could interfere with the 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
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