EUCTR2005-001282-34-DE进行中（未招募）不适用
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 500 人开始时间: 2006年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •-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 less than or equal to 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 (see list of prohibited concomitant medications, section 4.4).
- •-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.
- •-Patients with extrapyramidal symptoms
研究者
相似试验
进行中（未招募）
1 期
Safety & efficacy of SENS-111 in patients with acute vertigo due to inner ear diseaseAcute Unilateral VestibulopathyMedDRA version: 20.1Level: PTClassification code 10047393Term: Vestibular neuronitisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-003927-45-HUSensorion SA207
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 dyspepsiaEUCTR2005-001282-34-GBAXCAN PHARMA Inc.
进行中（未招募）
不适用
A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritisMedDRA version: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2007-006129-29-NLMorphoSys AG89
进行中（未招募）
1 期
Safety & efficacy of SENS-111 in patients with acute vertigo due to inner ear diseaseAcute Unilateral VestibulopathyMedDRA version: 20.1 Level: PT Classification code 10047393 Term: Vestibular neuronitis System Organ Class: 10021881 - Infections and infestationsEUCTR2016-003927-45-ESSensorion SA207
进行中（未招募）
不适用
study to assess the efficacy and safety of a herbal medicine (dry extract BNO-1016) in patients with chronic rhinosinusitisChronic RhinosinusitisEUCTR2011-003623-35-CZBionorica SE885