EUCTR2004-000448-26-GB进行中（未招募）1 期
A multicentre, randomized, double-blind, placebo-controlled study of the efficacy and safety of Itopride HCl in patients suffering from functional dyspepsia
Axcan Pharma Inc. (Axcan Pharma International BV is subsidiary of Axcan Pharma Inc.)0 个研究点目标入组 150 人开始时间: 2005年6月6日最近更新:
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
- 150
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
入选标准
- •-Male and female outpatients (18-65 Years).
- •-Patients need to meet the following Rome II criteria: (1)Presence of persistent or recurrent dyspepsia (pain or discomfort centered in the upper abdomen). Discomfort may be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea. (2) No evidence of organic disease that is likely to explain the symptoms. (3) No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (not IBS).
- •-All patients enrolled must have a negative upper GI endoscopies to exclude organic disease, such as esophagitis, gastric or duodenal ulcer, esophageal or gastric neoplasia, within 1 month prior to enrolment. At the time of the endoscopy, patients must have been off Proton Pump Inhibitors (PPIs) and H2-receptor antagonists for at least 14 days.
- •-Patients in whom heartburn is infrequent, not exceeding a frequency of one episode per week, and is subordinate to their abdominal pain or discomfort.
- •-Evidence of H. pylori negative status, as confirmed by either C-13 within 7 days prior to enrolment.
- •-Baseline severity of at least moderate on the LDQ (total score of 9 and above).
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients suffering mainly or exclusively from symptoms corresponding to reflux disease.
- •-Patients suffering from regurgitation and/or vomiting.
- •-Abnormal upper GI endoscopy findings
- •-Clinical evidence or diagnosis of gallbladder or biliary tract disease, pancreatic disease confirmed by upper abdominal ultrasound or diagnosis of chronic inflammatory bowel disease.
- •-Patients with clinically relevant ECG abnormalities such as a QRS duration > 110 msec, heart rate < 50 beats per minute or a QTc duration of >470 msec on the screening ECG.
- •-Patients with known arrhythmias, such as: chronic/paroxysmal atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or torsades de pointe”.
- •-Active psychiatric disorder.
- •-Health conditions that would interfere with the study objectives or might impair the compliance of the patient.
- •-Severe hepatic, renal, cardiac, metabolic, hematological or malignant diseases or clinically relevant deviations in laboratory values (AST/ALT) greater than twice the upper limit of normal, serum creatinine > 2 mg/dl, hyperthyroid or hypothyroid patient according to the medical judgement of the investigator.
- •-Patients with hypokalemia (serum potassium less than or equal to 4 mmol/l) and hypomagnesemia (serum magnesium < 1.7 mg/dl).
- •-Any known hypersensitivity to the ingredients of the investigational drug.
- •-Patients with a genetic disease called trimethylaminuria (fish odor syndrome).
- •-Patients with laxative abuse, as judged by the investigator.
- •-Patients with any known specific food intolerance (whose symptoms disappear completely and persistently if he/she does not eat the particular food, e.g., lactose intolerance).
- •-Smoker who has significantly changed his/her smoking habits within 14 days prior to administration of study medication, or non-smoker who has become a smoker within 14 days prior to administration of study medication.
- •-Pregnancy or lactation.
- •-Women with childbearing potential who do not apply a medically accepted method of contraception.
- •-Known alcoholism or drug abuse.
- •Participation in another clinical trial within one month prior to enrolment or during the course of the study.
- •-Celiac disease or enteropathy.
研究者
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