NCT04821310终止2 期
AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 43
- 试验地点
- 55
- 主要终点
- Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures
研究概览
简要总结
The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
详细描述
Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment:
- •Capable of giving signed informed consent/assent
- •Willingness and ability of the participant or parent/legal guardian to complete the eDiary
- •Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary.
- •Male and female participants aged 1 to 17 years.
- •Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center for Disease Control standard age and weight chart, for the participant's age.
- •To be considered a female of non childbearing potential, the participant must meet at least 1 of the following criteria :
- •Premenarchal: The investigator (or other appropriate staff) must discuss the participant's premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered "female participants of non childbearing potential" and must comply with the protocol requirements applicable to women of childbearing potential.
排除标准
- •Previous administration of an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation
- •History or presence of upper gastrointestinal anatomic or motor disorders
- •Family history of malignant hyperthermia
- •Known hypersensitivity to any Proton Pump Inhibitor, including pantoprazole or to any substituted benzimidazole or to any of the excipients.
- •Any disorder requiring chronic (daily) use of warfarin, heparin, other anticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potent inhibitors or inducers of CYP2C19 (eg, phenytoin, sulfamethoxazole, valproic acid, carbamazepine, and griseofulvin).
- •Serum creatine kinase levels >3 x upper limit of normal.
- •Known history of human immunodeficiency virus or clinical manifestations of acquired immune deficiency syndrome.
- •Active malignancy of any type, or history of a malignancy. Participants with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable.
- •Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before the Screening visit.
- •Alanine aminotransferase or blood urea nitrogen >2.0 upper limit of normal or estimated creatinine >1.5 X upper limit of normal for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before the Baseline Visit (Day 1).
- •Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •Has, in the Investigator's opinion, a serious chronic condition (eg, diabetes, epilepsy), which is either not stable or not well controlled and may interfere with the conduct of the study.
- •Has any condition possibly affecting drug absorption (eg, gastrectomy).
- •Prior or Concomitant Therapy:
- •Frequent, repeated use of oral or parenteral glucocorticoids (eg, prednisone, prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used.
- •Pregnant female participants; breastfeeding female participants.
- •Is unwilling or unable to comply with the Lifestyle Considerations section
研究组 & 干预措施
Arm 2 Half Dose Pantoprazole and matching placebo
Active Comparator
Half Healing Dose of pantoprazole
干预措施: Half Dose Pantoprazole plus matching placebo (Drug)
Arm 1 Full Dose Pantoprazole and matching placebo
Active Comparator
Full Healing Dose of pantoprazole
干预措施: Full dose Pantoprazole plus matching placebo (Drug)
结局指标
主要结局
Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures
时间窗: Week 24
Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.
次要结局
- Number of Participants With Change From Baseline in Physical Examinations and Vital Signs(Baseline up to 36 weeks)
- Incidence of Adverse Events (AEs)(Baseline up to 36 weeks)
- Number of Participants With Change From Baseline in Laboratory Tests Results(Baseline up to 36 weeks)
研究者
研究点 (55)
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