临床试验/NCT05587322

NCT05587322已完成3 期

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

Braintree Laboratories112 个研究点分布在 1 个国家目标入组 800 人开始时间: 2022年9月6日最近更新: 2024年7月24日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 800
试验地点: 112
主要终点: Percentage of 24-hour heartburn-free days

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

The objective of the Treatment Phase of the study is to evaluate the safety and efficacy of 4 weeks of once daily oral administration of BLI5100 low dose, BLI5100 high dose, or placebo in patients with NERD. The objective of the Extension Phase of the study is to evaluate the safety of extended exposure to once daily oral administration of BLI5100 low dose and BLI5100 high dose in patients with NERD.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged ≥18 years at the time of signing informed consent;
•Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;
•Have documented history of symptomatic GERD;
•Have no mucosal break(s) on the upper GI endoscopy performed during Screening;
•Have reported heartburn on ≥4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;
•Able to understand and comply with the protocol requirements;
•Willing and able to provide written informed consent at Screening;
•A female of reproductive potential defined as a non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure; or If a female of childbearing potential, agrees to use an acceptable form of birth control and avoid egg donation from the Screening Visit until 6 months after the last dose of study drug.
•If a male, agrees to use an acceptable form of birth control from the Screening Visit until 3 months after the last dose of study drug.
•If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug.

排除标准

•Unable to undergo an upper GI endoscopy;
•Presence of esophageal stricture, gastroesophageal varix (including post sclerotherapy or ligation), untreated Barrett's esophagus, gastric bleeding, infection, tumor, or gastric or duodenal ulcer on the upper GI endoscopy;
•o Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
•Diagnosed with erosive gastroesophageal reflux disease, acute upper GI bleeding, gastric ulcer or duodenal ulcer, or acute gastritis within 2 months prior to the upper GI endoscopy;
•Alarm symptoms such as odynophagia, severe dysphagia, upper GI bleeding, weight loss, anemia, or hematochezia within 4 weeks prior to Screening, unless the presumed malignancy is ruled out;
•History or suspicion of functional upper gastrointestinal disorders, such as:
•Functional heartburn, as described in the Rome IV criteria, or
•Functional dyspepsia, as described in the Rome IV criteria.
•History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease, or documented history of delayed gastric emptying;
•History of acid-suppressive, esophageal, or gastric surgery;
•o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.
•History of malignancy within the past 5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin);
•o Note: This is not applicable to patients who had complete response or pathological complete response and whose tumor had not recurred for at least 5 years from the date of last treatment, or patients whose tumor had been removed by endoscopic resection without any findings indicating recurrence of the tumor within 3 years.
•History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;
•History of alcoholism, chronic opiate use, or substance addiction in the 12 months before Screening or a positive urine drug screen for opiates or substances of abuse;
•Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening.
•Note: Retesting of a positive urine drug screen requires Medical Monitor approval. Positive urine drug screen for all drugs will require verification of prescription for the positive tested substance.
•Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder;
•o Note: A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is not exclusionary, as long as the patient is asymptomatic and well-controlled on stable treatment (ie, stable dose for >6 months prior to Screening), including non-medical therapy.
•Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;
•Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;
•Use of 2 or more commercial doses of reflux esophagitis-related medications (including H2 blockers, prostaglandins, mucosal protective agents, prokinetics, and antacids) within 1 week prior to the upper GI endoscopy at Screening;
•Requirement of persistent (>3 times per week for >30 days) use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study;
•o Note: Low-dose (≤100 mg/day) aspirin is allowed provided that it has been used for prophylaxis prior to study participation.
•If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of study drug;
•Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;
•Positive test result for H. pylori at Screening or diagnosis and treatment of H. pylori within 4 to 6 weeks prior to Randomization;
•o Note: Patients who test positive for H. pylori at Screening will be offered treatment according to local standard of care and may be re-screened for eligibility following completion of treatment.
•Abnormal laboratory results with clinical relevance at Screening as follows:
•Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase level of ≥2 × upper limit of normal (ULN);
•Total bilirubin level of ≥2 × ULN, unless Gilbert's syndrome is confirmed when direct bilirubin is ≤0.3 mg/dL;
•Estimated glomerular filtration rate <30 mL/min; or
•Serum magnesium <lower limit of normal.
•Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);
•Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;
•Involvement in another clinical study within 4 weeks of initiation of study drug; or
•Any other clinically relevant condition that would confound study endpoints or adversely affect patient compliance with the study procedures in the medical judgment of the Investigator or Medical Monitor based on previous medical history or findings on Screening assessments .

研究组 & 干预措施

BLI5100 Low Dose

Experimental

During the Treatment Period, patients will take BLI5100 low dose once daily, orally, for 8 weeks. During the Extension Period, patients will continue to take BLI5100 low dose once daily, orally, for 20 weeks.

干预措施: BLI5100 (Drug)

BLI5100 High Dose

Experimental

During the Treatment Period, patients will take BLI5100 high dose once daily, orally, for 8 weeks. During the Extension Period, patients will continue to take BLI5100 high dose once daily, orally, for 20 weeks.

干预措施: BLI5100 (Drug)

Placebo

Placebo Comparator

During the Treatment Period, patients will take placebo once daily, orally, for 8 weeks. In the Extension Phase, patients who received placebo in the Treatment Phase will be re-randomized to receive either BLI5100 low dose or BLI5100 high dose to take once daily, orally, for 20 weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage of 24-hour heartburn-free days

时间窗: 4 Weeks

次要结局

Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation)(4 Weeks)

研究者

发起方

Braintree Laboratories

申办方类型

Industry

责任方

Sponsor

研究点 (112)

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