A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Patients (Age 12 to 17 Years) with Irritable Bowel Syndrome with Diarrhea (IBS-D)

Allergan LTD0 个研究点目标入组 120 人开始时间: 2018年12月13日最近更新: 2022年4月19日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 120

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

•To be eligible to participate in the study, patients must meet the following criteria:
•1. Patient must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.
•2. Patient is a male or female outpatient, 12 to 17 years of age inclusive, at the time the patient provides assent for the study and parent/guardian/LAR has provided signed consent.
•3. Patient is able to read and understand the assessments in the eDiary.
•4. Female patients of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.
•5. Female patients who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Reliable contraception is defined as:
•a) Hormonal contraception (eg, oral contraceptive, contraceptive implant, or injectable hormonal contraceptive).
•b) Double-barrier method (eg, condom plus intrauterine device, diaphragm plus spermicide).
•6. Patient has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria*: Must include all of the following:
•1. Abdominal pain at least 4 days per month over at least 2 months associated
•with one or more of the following:
•a. Related to defecation
•b. A change in frequency of stool
•c. A change in form (appearance) of stool
•2. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
•3. Patient has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for >25% of bowel movements and Bristol stool types 1 or 2 for <25% of bowel movements that occur in the absence of laxatives
•*All criteria fulfilled for at least 2 months prior to Visit 1 (screening).
•7. Patient has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization).
•8. Patient has an average daytime abdominal pain score =2.0 over the 2 weeks prior to randomization.
•9. Patient has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks prior to randomization that occurs in the absence of laxatives.
•10. Patient has no clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), and clinical laboratory tests (clinical chemistry panel, liver biochemical tests, complete blood count, urine drug screen, urinalysis) after providing informed assent and after written consent is obtained, but before receiving the first dose of study treatment. (A central laboratory will be used to evaluate all urine [except urine pregnancy tests] and blood samples and will
•utilize reference ranges specific to a patient’s age and gender. ECGs will be performed and electronically transmitted to a central ECG laboratory for analysis by a pediatric cardiologist in accordance with the instructions provided by the central ECG laboratory. The Investigator will determine if a particular finding is clinically significant. [In making this determination, the Investigator will consider whether the particular finding could represent a condition that would exclude the patient from the study, could represent a safety concern if the patient participates in the study, or could confound the study-specific a

排除标准

•Patients who meet any of the following criteria will not be eligible to participate in the study:
•1.has no gallbladder
•2.has had any of the following surgeries:
•a)Any abdominal surgery within the 3 months prior to trial;
•b)A history of major gastric, hepatic, pancreatic, or intestinal surgery
•3.has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
•4.has a history of pancreatitis; structural diseases of the pancreas, known or
•suspected pancreatic duct obstruction
•5.has a history of cholecystitis within 6months before trial.
•6.has known or suspected bile acid malabsorption.
•7.is a current regular alcohol drinker and/or binge drinker, and/or has a history
•of alcoholism, alcohol abuse, or alcohol addiction, and/or intends to consume alcohol during the trial.
•8.has had chronic or severe constipation or sequelae from constipation,
•or known or suspected mechanical GI obstruction or pseudo obstruction.
•9.has had or current diagnosis of constipation with encopresis.
•10.meets the child/adolescent Rome IV criteria of IBS with constipation, IBS
•with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.
•11.has had intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.
•12.has a history of hepatic impairment as defined by Child-Pugh Classification Grade A,B or C
•13.has a history or current diagnosis of inflammatory or immune-mediated lower
•GI disorders including inflammatory bowel disease
•14.has celiac disease,or a positive serological test for celiac disease and the
•condition has not been ruled out by endoscopic biopsy
•15.has any congenital and/or acquired malabsorption syndrome
•16.has a history of a microbiologically documented GI infection within 3months prior to trial
•17.has a known lactose or fructose intolerance
•18.has a history of diverticulitis within 3 months prior to trial
•19.has had within 5 years prior to trial or current evidence of laxative abuse
•20.has a history of either hypo-or hyperthyroidism that is untreated or treated
•with medication at a dose that has not been stable for at least 3months prior to
•21.Patient’s diarrhea is deemed by the Investigator to be caused by infectious
•22.has had or current evidence of blood in the stool
•23.currently has both unexplained and clinically significant alarm symptoms and systemic signs of infection or colitis, or any neoplastic process
•24.has a history or current diagnosis of eosinophilic gastroenteritis
•25.has Cystic Fibrosis, and or any other causes of pancreatic exocrine insufficiency
•26.is receiving enteral tube feeding
•27.has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6months prior to trial
•28.has an unstable renal, hepatic, metabolic, or hematologic condition
•29.has a history of malignancy within 5 years before Screening, which includes any new diagnosis of malignancy or any treatment for or recurrence of a malignancy that was diagnosed 5 or more years prior. In order to be eligible for the study, patient must be malignancy free for the past 5years
•30.has a history of immunodeficiency
•31.has a history of drug abuse
•32.has a positive urine drug result
•33.has a weight and BMI less than the 3rd percentile.
•34.has had an unintentional weight loss greater than or equal to 5% of his/her
•body weight

研究者

发起方

Allergan LTD

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