A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
研究概览
简要总结
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Male or female participants must be 6 to 17 years of age (inclusive)
- •Participants must have completed study intervention in their lead-in study
排除标准
- •Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
- •Participant has known allergies or hypersensitivity to opioids
- •Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
- •Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
- •Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
- •Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
- •Participant has a history of chronic or severe constipation, or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction
- •Participant has renal impairment or an unstable hepatic, metabolic, or hematologic condition.
- •Participant is a current regular alcohol drinker and/or binge drinker*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking*), or alcohol addiction, and/or intends to consume alcohol during the study
研究组 & 干预措施
Open Label 6-11 years of age: Eluxadoline 50mg
Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.
干预措施: 25mg Eluxadoline (Drug)
Open Label 12-17 years of age: Eluxadoline 100 mg
Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.
干预措施: 25mg Eluxadoline (Drug)
Open Label 12-17 years of age: Eluxadoline 100 mg
Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.
干预措施: 100mg Eluxadoline (Drug)
Double Blind 6-11 years of age: Eluxadoline 25mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
干预措施: 25mg Eluxadoline (Drug)
Double Blind 6-11 years of age: Eluxadoline 50mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
干预措施: 25mg Eluxadoline (Drug)
Double Blind 12-17 years of age: Eluxadoline 25mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
干预措施: 25mg Eluxadoline (Drug)
Double Blind 12-17 years of age: Eluxadoline 50mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
干预措施: 25mg Eluxadoline (Drug)
Double Blind 12-17 years of age: Eluxadoline 100mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
干预措施: 25mg Eluxadoline (Drug)
结局指标
主要结局
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
时间窗: 52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
时间窗: 52 weeks
Percentage of Participants with Adverse Events
时间窗: 52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
时间窗: 52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
时间窗: 52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
时间窗: 52 weeks
次要结局
未报告次要终点