A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 35
- 主要终点
- Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups
研究概览
简要总结
The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to <18 years. The main questions it aims to answer are:
- Does plecanatide increase the number of spontaneous bowel movements (SBMs) compared to placebo?
- Is plecanatide safe and well tolerated in this pediatric population? Researchers will compare plecanatide at different doses to a placebo (a look-alike substance with no active drug) to see if plecanatide improves bowel function.
Participants will:
- Take plecanatide or placebo orally once daily for 4 weeks
- Complete daily symptom diaries
- Attend clinic visits for assessments and safety checks
详细描述
This study is a randomized, double-blind, placebo-controlled, dose-ranging clinical trial designed to evaluate the safety, efficacy, and pharmacokinetics of plecanatide in pediatric patients aged 6 to <18 years with irritable bowel syndrome with constipation (IBS-C). IBS-C is a condition that causes abdominal pain and infrequent, hard bowel movements.
The study includes two age cohorts:
Group A: 6 to 11 years Group B: 12 to <18 years
Participants are randomly assigned to receive one of four plecanatide doses (0.5 mg, 1.0 mg, 2.0 mg, or 3.0 mg) or placebo. All treatments were taken orally once daily for 4 weeks following a 28-day screening/baseline period. After treatment, participants were followed for 2 weeks.
The primary objective is to determine whether plecanatide increases the number of spontaneous bowel movements (SBMs) compared to placebo.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1.0 mg plecanatide - Group A
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
干预措施: Plecanatide (Drug)
0.5 mg plecanatide
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
干预措施: Plecanatide (Drug)
2.0 mg plecanatide
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to 18 Years of Age
干预措施: Plecanatide (Drug)
3.0 mg plecanatide
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old
干预措施: Plecanatide (Drug)
Matching placebo - Group A
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
干预措施: Matching placebo (Drug)
1.0 mg plecanatide - Group B
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: ≥ 12 to < 18 Years of Age
干预措施: Plecanatide (Drug)
Matching Placebo - Group B
Matching placebo Taken orally daily for 4 weeks Group B: 12 to < 18 years old
干预措施: Matching placebo (Drug)
结局指标
主要结局
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups
时间窗: Baseline to Week 4
Weekly SBM rate computed for each week
次要结局
- Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..(Baseline to Week 4)
- Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..(Baseline to Week 4)
- Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM)(Baseline to Week 6)
- Change From Baseline in Frequency of Bowel Movements (BM)(Baseline to Week 4)
- Change From Baseline in Frequency of Fecal Incontinence(Baseline to Week 4)
- Time to First Bowl Movement (in Days)(Day 1 to first BM during Treatment Period)
- Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C)(Baseline to Week 4)
- Use of Rescue Medication(Baseline to Week 4)
- Change From Baseline in Severity of Defecation Pain(Baseline to Week 4)
- Change From Baseline in Frequency of Pain With Defecation(Baseline to Week 4)
- Change From Baseline in Frequency of Large Diameter Stools(Baseline to Week 4)