A phase III, multicenter, double blind, controlled, randomized, parallel-design study to evaluate the efficacy and safety of Combizym® Compositum compared with placebo in subjects with Functional Dyspepsia according Rome III Diagnostic Criteria.

DEUTSCHE PHARMA S.A.C.,0 个研究点目标入组 122 人开始时间: 2016年8月16日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Sign and date an inform consent form according Good Clinical Practices guidelines and local regulations approved by ethics committee in research where explains all aspects of the protocol.
•2. Subjects both sexes between 18 to under 65 years of age.
•3. Diagnosis of functional dyspepsia having been discard digestive organic disorders that could explain the patient´s symptoms.
•4. One or more symptoms of dyspepsia including: bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning.
•5. Willingness to adhere to the treatment program.

•1. Participation in another research study concurrently or within the last thirty (30) days.
•2. A significant clinical or psychiatric disorder, acute or chronic, which at the investigator’s judgement, may endanger the subject’s safety, limits the subject’s ability to complete the study, and/or affects the objectives of the study.
•3. Subjects who had been treated with H2 receptor antagonists, prokinetic agents and use of digestive enzymes within 7 days of the Screening Visit ((Visit 1), or who have programed to receive any of the products during the study. Oral analgesic products are not allowed except for PRN paracetamol.
•4. Subjects with organic digestive disorders, severe hepatic failure, biliary tract obstruction, vesicular empyema or gastrointestinal infections.
•5. Subjects with serious pulmonary or cardiovascular disorders, late stage cancer, unstable chronic diseases or acute diseases that may influence the evaluation of the study.
•6. Allergy history or hypersensitivity to investigational product or any of its components.
•7. Female subjects who are pregnant of breast-feeding.
•8. Female patients of reproductive age who are not using appropriate efficient contraceptive methods.
•9. Investigators, staff medical center directly affiliated with this study and their immediate families. It is defined as an immediate family member / a husband / wife, father / mother, son or descendant, whether biological or legally adopted.

发起方

DEUTSCHE PHARMA S.A.C.,