EUCTR2006-001316-76-DE进行中（未招募）不适用
A randomized, open, parallel-group, multi-centre, phase IV study toevaluate the efficacy of three different patient management strategies withand without esomeprazole 20 mg during a 3 months maintenance phasefollowing an initial 4-weeks acute treatment phase in subjects withsymptoms thought to be GERD related - SYMPATHY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,600
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. Signed informed consent from the subject prior to conducting any study-related procedures.
- •2. Males or females aged between 18 and 50 years.
- •3. Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
- •4. Subjects should be eligible for empirical treatment for up to 16 weeks with either esomeprazole and / or rescue medication (antacids) according to physician’s judgement.
- •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. Subjects with any clinical GERD diagnosis / treatment (PPI, H2-receptor antagonists) within last 3 months prior to Visit 1.
- •2. Subjects with a history of severe esophagitis (i.e. LA grade C or D) or known other complications (e.g. Barrett‘s esophagus, stricture).
- •3. Previous anti-reflux surgery, or any form of upper gastrointestinal resective surgery.
- •4. Subjects with alarm symptoms such as unintentional weight loss, dysphagia, disturbed food passage, persistent vomiting, haematemesis, melena and jaundice.
- •5. Any other signs / suspicions indicating serious or malignant disease.
- •6. Subjects with dominant symptoms suggestive of peptic ulcer disease or dyspepsia (functional dyspepsia is defined as persistent or recurrent pain or discomfort centred in the upper abdomen [Rome II criteria]).
- •7. Subjects with chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and / or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome, or two or more of the following criteria:
- •- visible abdominal distention,
- •- pain relieved by a bowel action,
- •- more frequent stools with the onset of pain,
- •- looser stools with the onset of pain,
- •- rectal passage of mucus,
- •- a sensation of incomplete defecation.
- •8. Any significant past or current disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study or subject’s ability to participate in the study.
- •9. Subjects with a need for a NSAID therapy or an ASA therapy with a daily dose > 325 mg.
- •10. Subject judged by investigator not to be capable to understand and complete PRO Questionnaires reliably.
- •11. Subjects taking contraindicated concomitant medication according to local Market Data Sheet (MDS).
- •12. Pregnancy or lactation. Women of childbearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy. Acceptable methods include implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or sterilisation (including vasectomy).
- •13. Subjects with a known hypersensitivity to any component of esomeprazole or rescue medication used in the study.
- •14. Planned donation of blood during the study participation.
- •15. Planned hospitalization during the study participation.
- •16. History of alcohol or drug abuse in the last two years or any condition associated with poor compliance, including expected non-cooperation, as judged by the investigator.
- •17. Participation in another clinical study of any investigational drug within 30 days prior to start or during the course of the study.
- •18. Previous enrolment in this study.
- •19. Involvement in the planning and conduct of the study (applies to both, AstraZeneca staff or staff at the study site).
研究者
相似试验
已完成
不适用
An open, randomized, parallel group, multi-center study on the effect of a resume of Renal Anemia Treatment by Erythropoietin supplemented with Iron and vitamin C on the Prognosis in Hemodialysis PatientsRenal anemia in maintenance dialysis patientsJPRN-C000000316Department of Kidney and Dialysis, Hyogo College of Medicine450
进行中（未招募）
不适用
Comparison of three different doses of PEG-rASNase and Oncaspar in treatment of adult patients with acute lymphoblastic leukaemiaAcute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in the bone marrow leads to suppression of normal haematopoiesis as well as disseminated infiltration of organs and release of blasts into periphal blood.MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-020613-91-DEmedac Gesellschaft für klinische Spezialpräparate mbH
进行中（未招募）
不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic vs. a standard dosing regimen of Myfortic in combination with Neoral and Corticosteroids in de novo renal transplant patientsProphylaxis of the rejection after renal transplantMedDRA version: 14.1Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2006-003633-32-ITOVARTIS FARMA306
进行中（未招募）
不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patientsProphylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplantsEUCTR2006-003633-32-BEovartis Pharma Services AG306
进行中（未招募）
不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patientsProphylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplantsEUCTR2006-003633-32-SEovartis Pharma Services AG306