EUCTR2010-022082-10-BG进行中（未招募）不适用
A double-blind, double-dummy, randomised, study to assess the superiority of Zegerid® 20 mg vs. Losec® 20 mg in the rapid relief of heartburn associated with GERD as on demand therapy.
orgine Ltd0 个研究点目标入组 300 人开始时间: 2011年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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. Male or female, between 18 and 75 years old.
- •2. History of frequent episodes of heartburn associated with GERD for at least 2-3 days per week during 2-4 weeks before screening and have responded to standard PPI therapy in the past 12 months.
- •3. Have not taken on-demand PPI therapy for >3 consecutive days within 4 weeks before the screening period.
- •4. The patient’s written informed consent must be obtained prior to inclusion.
- •5. Willing and able to complete the entire procedure and to comply with study instructions.
- •6. Females of childbearing potential must employ an adequate method of birth control.
- •Inclusion criteria applicable to Screening period:
- •1. Recorded at least 1 evaluable episode of heartburn on 2 separate days at level 4 or higher on the 9-point Likert severity scale (point 3 on a 0-8 point scale) prior to randomisation.
- •2. Competence in the use and completion of the e-diary.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age <18 or >75 years old.
- •2. Intake of any medication for the purpose of the eradication of H. pylori during the last 28 days before the start of the study.
- •3. Intake of systemic glucocorticoids or NSAIDs including COX-2-inhibitors (=3 consecutive days per week) during the last 28 days before the start of the study; except regular intake of enteric coated aspirin dosages up to 150 mg/d.
- •4. Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (excluding: appendectomy, cholecystectomy and polypectomy).
- •5. History of co-existing disease that affects the oesophagus (e.g. Barrett’s oesophagus, Zollinger-Ellison syndrome, oesophageal stricture), and have undergone an endoscopy with results of incomplete healing of erosions following standard PPI therapy within the last 3 months.
- •6. History of active gastric or duodenal ulcers within 3 months of the first dose of the study drug or had acute upper GI bleeding within last 6 months.
- •7. Documented presence of severe renal or hepatic insufficiency.
- •8. Known hypersensitivity to omeprazole.
- •9. Concurrent participation in a study with an investigational drug or participation within 30 days of study entry.
- •10. Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control (the use of the combined oral pill, progestogen only pill, combined contraceptive patches, depot contraceptives or double barrier method all are acceptable as a reliable form of contraception).
- •11. Clinically significant laboratory abnormality or disease which, in the opinion of the Investigator, will create a risk for the patient, obscure the effects of study treatment or interfere with study results.
- •12. Received any of the following drugs within 2 weeks before the first dose of randomised study medication or continue to need these drugs for concurrent therapy: theophylline, bismuth salts, warfarin, phenytoin, tracolimus, diazepam, cyclosporine, disulfiram, benzodiazepines, barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate clopidogrel or protease inhibitors.
- •13. Taking concomitant medications that rely on the presence of gastricacid for optimal bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
- •14. Onset of psychiatric medication (e.g. depressants, stimulants or hallucinogens) in the previous 6 months and during the entire course of the study.
- •Exclusion criteria applicable to Screening period:
- •1. Recorded <1 episode of heartburn on 2 separate days at level 4 or higher on the 9-point Likert severity scale (point 3 on a 0-8 point scale) during the 7 day screening period prior to randomisation.
- •2. Completing <90% (9 out of 10) of the time points with evaluable data on their e-diary.
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