EUCTR2006-000257-22-GB进行中（未招募）1 期
A study to assess the effectiveness of esomeprazole 40 mg once daily in subjects with continuing gastroesophageal reflux disease (GORD) symptoms following treatment with a previous full dose proton pump inhibitor (PPI). An 8 week, open label, multicentre study. - RESPONSE study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •1.Signed and dated informed consent will be obtained before any study related procedure is conducted.
- •2.Male or female aged ³ 18 years
- •3.Current treatment for GORD with a PPI at a full dose, given once daily, for a period of up to 8 weeks
- •4.Persisting GORD symptoms of heartburn, acid regurgitation or epigastric pain 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)
- •·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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •presence of one or more of these criteria will exclude the patient
- •1.More than 1 previous course of full dose PPI in the last 12 months (excluding the current course)
- •2.Current treatment for GORD with a full dose PPI for more than 8-weeks
- •3.Previous use of esomeprazole
- •4.Subjects using an H2 receptor antagonist (either prescribed or OTC)
- •5.Documented medical history or gastrointestinal pathology such as:
- •·Gastrointestinal malignancy
- •·Zollinger-Ellison syndrome; malabsorption
- •·Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study
- •·Unstable diabetes mellitus as judged by the investigator to interfere with the evaluation of the study
- •6.Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: Previous lower gastrointestinal surgery such as appendectomy, colonic resection, cholecystectomy, or gynaecological surgery are not exclusion criteria
- •7.Presence of Irritable Bowel Syndrome as judged by the investigator. This is characterised by chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating·
- •8.Presence of any alarm symptoms suggestive of organic disease, including but not limited to, vomiting, GI bleeding or anaemia, abdominal mass, unexplained weight loss and dysphagia
- •9.Severe, concurrent disease or mental illness that may complicate the study evaluation or affect subject compliance as judged by the Investigator
- •10.Requirement for continuous concurrent therapy with the following medications during the study period:
- •Sucralfate, quinidine, warfarin and other vitamin K antagonists, phenytoin, bisphosphonates, methotrexate, antidepressants (therapy less than 3 days per week is acceptable), prostaglandin analogues such as misoprostol, ketoconazole, fluconazole, itraconazole, diazepam, cisapride
- •11. Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test and maintain contraception during the study medication treatment period. Investigators should be satisfied that those women who are not surgically sterilized or are < 1 year post-menopausal are not pregnant at study entry. Any contraceptive measure with a less than 1% failure rate will be considered acceptable (birth control pill, IUD, Depo-Provera®) or double-barrier method (e.g. condom and spermicide, diaphragm and contraceptive foam).
- •12.Chronic alcoholism, drug abuse, or psychological condition judged by the investigator to potentially result in poor subject compliance or interfere with study evaluation.
- •13.Suspected or confirmed current malignancy except basal cell carcinoma. Current is defined as: any malignancy, except basal cell carcinoma, that has been active within the previous 12 months
- •14.Known hypersensitivity to esomeprazole or any of its constituents
- •15.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- •16.Previous enrolment or randomisation of treatment in the present
研究者
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