A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive gastroesophageal Reflux Disease (GERD) - Not applicable

Eisai Limited0 个研究点目标入组 1,060 人开始时间: 2008年10月15日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Eisai Limited
入组人数: 1,060

研究概览入排标准研究者记录与标识符相似试验

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

•Male or female, ages 18 to 75 years.
•History of GERD symptoms (such as acid regurgitation, dyspepsia, chest or epigastric pain) for at least 3 months immediately before screening
•Heartburn for at least 2 days a week for at least 1 month before screening
•Esophageal erosions of LA grades C or D based on EGD taken within 14 days prior to enrollment
•Subjects who are H. Pylori negative based on Urea Breath Test (UBT)
•Females should be either of nonchildbearing potential (defined as having undergone surgical sterilization, or postmenopausal [age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must have a negative serum ß-human chorionic gonadotropin (ß-hCG) at Visit 1 and negative urine pregnancy test prior to randomization at Visit 3. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception (e.g., abstinence, or a double-barrier method [e.g., condom + spermicide, condom + diaphragm with spermicide], or intrauterine device, or have a vasectomized partner) starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Visit 1 and continuing throughout the entire study period and for 1 month after the last dose of study drug. Pregnant and/or lactating females are excluded.
•Subjects must be able to read, write, and understand the language of the symptom 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

•Subjects who are known to be HIV-positive
•Subjects who experience drastic weight loss (>10% total weight) during the 2-month period prior to screening
•Use of prescription or non-prescription PPIs or histamine (H2) receptor antagonists within 2 weeks before the screening EGD or the SOC EGD, if subjects undergo alternative screening procedures.
•Use of antimicrobials, PPIs or bismuth preparations within 2 weeks before the UBT for H. pylori screening
•Use of antacids during the study, except for study-supplied antacid
•Current or a history of oesophageal motility disorders (achalasia, scleroderma, or oesophageal spasm)
•Current or a history of Barrett's esophagus current oesophageal strictures. Oesophagitis (known or suspected to be due to aetiology other than GERD such as infection, medications).
•Current or a history of Zollinger-Ellison syndrome and other acid hyper-secretory conditions, or current gastric or duodenal ulcer.
•Current or a history of cancer with the exception of fully excised skin basal cell carcinoma
•Inflammatory bowel disease
•Unstable diabetes mellitus
•History of oesophageal, gastric and duodenal- surgery except simple suturing of an ulcer
•Subjects with clinically relevant abnormal laboratory tests at the screening visit, including liver enzymes greater than 2 times the upper limit of normal
•Evidence of significant hepatic, renal, respiratory, endocrine, haematologic, neurologic, psychiatric, or cardiovascular system abnormalities, unless the sponsor and investigator agreed that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study
•Females who are pregnant or lactating
•Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study
•Subjects who have participated in another investigational drug study within 30 days prior to screening or were expected to receive an investigational drug during this trial
•Subjects with a history of allergy or sensitivity to any component of Aciphex®, Nexium®, or antacid
•Active alcohol and substance abuse
•Subjects who were unable or unwilling to give informed consent.
•Subjects who were unable or unwilling to complete a daily diary.
•Subjects who were unable or unwilling to return for all required study visits.
•Subjects who are unable or unwilling to abide by requirements of the study or violate the restrictions of the study as related to prohibited medications (defined in Section 10.6.3)
•Subjects with difficulty in swallowing the study medication
•Subjects who require daily use of non-steroidal anti-inflammatory drugs (NSAIDs), oral steroids (=20 mg/day prednisone or equivalent), or aspirin (>325 mg/day).

研究者

发起方

Eisai Limited

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