EUCTR2005-000458-57-SE进行中（未招募）不适用
A randomised, open, phase IV, parallel group multicentre study to evaluate a change of management in Gastroesophageal Reflux Disease (GERD) patients by treatment with esomeprazole 40 mg or any other Proton Pump Inhibitor (PPI), after initial treatment failure, in ordinary clinical practice during 4 weeks. - IMPROVE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Provision of informed consent
- •2.Male or female, age 18-65 years
- •3.History of GERD symptoms during, at least, six months prior to enrolment.
- •4.PPI as maintenance and/or as needed treatment during the last 30 days prior to enrolment.
- •5.Heartburn as predominant GERD symptom, as judged by the investigator
- •6.Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the subject as either: 4 days with mild symptoms (i.e. awareness of sign or symptom , but easily tolerated) or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
- •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
- •1.Treatment with esomeprazole during 30 days prior to enrolment
- •2.History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer
- •3.Patients with current or historical evidence of the following diseases/conditions, as judged by the investigator:
- •·Zollinger-Ellison syndrome
- •·Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm
- •·Gastric or duodenal ulcers within the last three months
- •·Malabsorbtion
- •·Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study
- •·Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable
- •·Patients with severe diseases or disorders which may interfere with the conduct of the study
- •4.Any alarm symptoms” such as unintentional weight loss, GI bleeding, dysphagia, jaundice or any other sign indicating serious or malignant disease.
- •5.Patients with known history of complications of GERD such as esophageal stricture needing intervention or known significant dysplastic changes in the esophagus.
- •6.Patients with symptoms that in the opinion of the investigator are likely to be due to Irritable Bowel Syndrome (IBS), or subjects who fulfil two or more of the following criteria:
- •·symptoms relieved by defecation
- •·symptoms associated with change in frequency of stool
- •·symptoms associated with change in form of stools
- •7.Patients with need of continuous concomitant therapy with
- •·Drugs with antikolinergic effect
- •·Prostaglandin analogues
- •·NSAIDs (sporadic use with up to 2 tabl per week is allowed)
- •·ASA (except for 165 mg daily or less for cardiovascular prophylaxis)
- •·H2-receptor antagonists
- •8.Contraindications to the study drug, e.g. known or suspected allergy to esomeprazole
- •9.Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator
- •10.Suspected poor capability to follow instructions of the study, e.g. because of difficulty to read/understand Swedish, a history of drug abuse, or any other reason, as judged by the investigator.
- •11.Previous randomisation of treatment in the present study or participation in a clinical study during the last 30 days
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