EUCTR2005-001282-34-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.0 个研究点目标入组 0 人开始时间: 2005年4月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 old.
- •- 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 characterized 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 had 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 (i.e. burning, retrosternal pain) 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 or with biopsy at endoscopy.
- •- Signed informed consent at screening visit.
- •- Patient is on a stable diet and will remain on it for the duration of the study.
- •- 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, e.g., esophageal, gastric erosions, ulcers.
- •- Patients for whom the symptoms are exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (not irritable bowel syndrome).
- •- Clinical evidence or diagnosis of gallbladder or biliary tract disease, pancreatic disease confirmed by upper abdominal ultrasound.
- •- Clinical evidence 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 that would interfere with the study objectives.
- •- Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient.
- •- Severe hepatic, renal, cardiac, metabolic, hematological or malignant diseases (including prolactin dependent tumors) 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 judgment of the investigator. Patients with hypokalemia (serum potassium < or = 4.0 mmol/l) and hypomagnesemia (serum magnesium < 1.7 mg/dl).
- •- History of 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 (e.g., hysterectomy, sterilization, oral 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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