EUCTR2020-003319-91-HU进行中（未招募）1 期
A randomized double-blind, double dummy, active comparator-controlled dose finding study in patients with reflux esophagitis Los Angeles grade C or D, and patients with at least partial symptom response but endoscopically still unhealed after 8 weeks history of standard treatment healing course with proton-pump inhibitor (PPI), to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or lansoprazole, and symptom pattern during subsequent 4 weeks treatment with lansoprazole
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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. Written informed consent must be obtained before any study related assessment is performed.
- •2. Male or female patient aged 18-75 years inclusive at the time of obtaining the informed consent .
- •3. Body mass index (BMI) = 18 and = 40 kg/m2 at screening
- •4. Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:
- •LA grade C or D =5 days before randomization (with or without historical PPI treatment)
- •LA grade A or B =5 days before randomization
- •history of treatment with standard healing course of PPI for minimum of 8 weeks prior to screening and =5 days of non-treatment during this period.
- •at least partial symptom response during the minimum of 8 weeks of PPI treatment.
- •Note: partial symptom response is defined as a clear symptom improvement (heartburn or regurgitation) after start of the PPI treatment course
- •(Investigator´s standardized question to the patient: Did you feel a clear symptom improvement (heartburn or regurgitation) after you started the PPI treatment course? Patient´s response must be YES or NO)
- •5. Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.)
- •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 156
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •1. Female pts of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using one of the following adequate methods of contraception during dosing and for at least 7 days after the last dose of study medication:
- •Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- •Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking the first dose of study treatment. In case of oophorectomy alone, only when the reproductive status of the patient has been confirmed by follow-up hormone level assessment
- •Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that pt.
- •Placement of a non-hormonal IUD
- •Double barrier methods of contraception: condom in combination with occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/vaginal suppository
- •2.Female pts of non-childbearing potential do not need to use a contraceptive method.
- •3.Male pts with a partner of childbearing potential, unless they are willing to use condoms in combination with a second method of adequate contraception (e.g. double barrier method), and they agree not to father a child during dosing and for at least 7 days after the last dose of study medication. Each male pt will be considered as potent unless surgically sterilized (at least 6 months prior to screening).
- •4.History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the study results or the patient’s ability to participate in the study
- •5.Patients with so-called alarm features” in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract. Exclusion can be based on symptoms only.
- •6.Present clinically significant psychiatric diagnosis, at discretion of the Investigator
- •7.History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years.
- •8.History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, bowel resection or transjugular intrahepatic portosystemic shunt (TIPS)
- •9.Known severe atrophic gastritis
- •10.Any planned major surgery within the duration of the study
- •11.Any clinically significant laboratory parameter outside reference value that, in the opinion of the Investigator, may suggest a new or insufficiently understood disease, may present an unreasonable risk to the pt as a result of his/her participation in the study, or may interfere with study assessments.
- •12.History of a positive result for HIV, HBsAg, anti-HBcAg, or anti
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