A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Proportion of Overall Responders
研究概览
简要总结
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation.
详细描述
The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo, when administered for 8 weeks in adolescents with chronic idiopathic constipation.
This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adolescents 12 to less than 18 years of age.
- •Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).
- •Patient is able to voluntarily provide written, signed, and dated (personally and via a legally authorized representative [LAR]) assent/informed consent as applicable to participate in the study.
- •Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures (e.g., accept venipuncture, willing and able to swallow tablets, accept urine drug screen for opiates) and restrictions.
排除标准
- •The patient has a mental age <4 years in the investigator's opinion.
- •The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation.
- •The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor.
- •The patient, if female of childbearing potential (defined as postmenarche), does not agree to practice 1 of the following medically acceptable methods of birth control throughout the study:
- •Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before study drug administration.
- •Total abstinence from sexual intercourse since the last menses before study drug administration.
- •Intrauterine device.
- •Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream.
- •The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days weeks prior to Screening.
- •The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion.
- •The patient has a history of an eating disorder.
研究组 & 干预措施
Plecanatide 0.5 mg
Taken orally once daily in the morning for 8 weeks
干预措施: Plecanatide (Drug)
Plecanatide 1.0 mg
Taken orally once daily in the morning for 8 weeks
干预措施: Plecanatide (Drug)
Plecanatide 1.5 mg
Taken orally once daily in the morning for 8 weeks
干预措施: Plecanatide (Drug)
Matching placebo
Taken orally once daily in the morning for 8 weeks
干预措施: Matching placebo (Drug)
结局指标
主要结局
Proportion of Overall Responders
时间窗: 8 weeks
An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had \>3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.
次要结局
- Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score(8 weeks)
- Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)(8 weeks)
- Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)(8 weeks)