EUCTR2012-004296-39-BE进行中（未招募）1 期
Functional Dyspepsia: validation of a questionnaire for symptom assessment in patients suffering from Postprandial Distress Syndrome (Functional Dyspepsia): assessment of sensitivity to change in PDS symptom severity in an interventional study
Targid University Leuven0 个研究点目标入组 100 人开始时间: 2013年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •1.Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see APPENDIX 1.B)
- •2.Patients must provide witnessed written informed consent prior to any study procedures being performed
- •3.Patients aged between 18 and 70 years inclusive
- •4.Male or female patients
- •5.Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements
- •At visit 2:
- •6.Patients suffering from active PDS (Rome III) as per LPDS scoring system (See Focus Group study) during the 2 weeks eligibility period.
- •Postprandial fullness and/or early satiation should be present at least 4 days during the 2 weeks eligibility period with at least moderate intensity.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •At visit 1:
- •1.Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- •2.Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). Patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline) during the last 3 months are eligible.
- •3.Females who are pregnant or lactating.
- •4.Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months.
- •5.Patients suffering from diabetes type 1 or type 2.
- •6.Patients taking prohibited medication will need a wash-out period of 2 weeks before they can be screened (see 3.2.1).
- •7.Patients with well-known hypersensitivity to gastroprokinetic drugs.
- •8.Patients with confirmed gastro-intestinal disease.
- •9.Patients with former digestive surgery affecting the gut motility.
- •10.Patients affected by concomitant disease responsible for digestive symptoms
- •11.Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
- •12.Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10).
- •13.Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9).
- •14.Patients presenting vomiting more than one day a month
- •15. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19).
- •16.Patients presenting predominant GERD according to GERD questionnaire (> two yes” answer to question 21).
研究者
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