A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age with Functional Constipation (FC).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 13
- 主要终点
- Change from baseline in 4-week overall SBM frequency rate (SBMs/week) during the Study Intervention Period
研究概览
简要总结
Objective for Part 1: To identify a tolerable, safe, and efficacious dose of linaclotide administered for 4 weeks in pediatric subjects, 6 months to less than 2 years of age, with FC for Part 2.
Objective for Part 2: To evaluate the safety and efficacy of 4 weeks of study intervention with linaclotide in pediatric participants, 6 months to less than 2 years of age, with FC.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •The Subjects' LAR/parent/guardian must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Individuals must be 6 months to less than 1 year and 11 months old, at the time the LAR/parent/guardian signs the informed consent in alignment with local requirements.
- •Subject has weight-for-height/length ratio of ≥ 3rd percentile for age 6 months to less than 24 months at the time the LAR/parent/guardian has provided signed consent. (Investigators can choose to use CDC or WHO growth charts based on their current clinical practice).
- •Subject meets Rome IV criteria for FC as outlined below: For at least 1 month before Screening (Visit 1), the subject must meet 2 or more of the following (a-e): a) 2 or fewer defecations per week (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) b) History of excessive stool retention c) History of painful or hard bowel movements (BMs) d) History of large-diameter stools e) Presence of a large fecal mass in the rectum Accompanying symptoms may include irritability, decreased appetite, and/or early satiety.
- •Based on the eDiary, the Subject has an average of ≤ 2 spontaneous bowel movements (SBMs) per week during the 14 days before the enrollment/randomization day and up to the enrollment/randomization (including the morning eDiary assessments reported before administration of first dose of study intervention on the enrollment/randomization day). An SBM is defined as a bowel movement (BM) that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM.
排除标准
- •Subjects with conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
- •Subjects with history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
- •Subjects with conditions of unexplained AND clinically significant alarm symptoms (lower gastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
- •Subjects with suspected mechanical bowel obstruction or pseudo-obstruction
- •Subject did not use a protocol-specified prohibited medicine before the start of the Preintervention Period (Visit 2) or failed to meet the stable-dose requirements of certain medications
- •Subject must not have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Screening (Visit 1) or is currently or planning to enroll in another clinical study or was previously enrolled in this study.
结局指标
主要结局
Change from baseline in 4-week overall SBM frequency rate (SBMs/week) during the Study Intervention Period
Change from baseline in 4-week overall SBM frequency rate (SBMs/week) during the Study Intervention Period
Change from baseline in 4-week stool consistency (Bristol Stool Form Scale) reported by legally authorized representative (LAR)/parent/guardian/caregiver during the Study Intervention Period
Change from baseline in 4-week stool consistency (Bristol Stool Form Scale) reported by legally authorized representative (LAR)/parent/guardian/caregiver during the Study Intervention Period
Change from baseline in 4-week straining reported by LAR/parent/guardian/caregiver during the Study Intervention Period
Change from baseline in 4-week straining reported by LAR/parent/guardian/caregiver during the Study Intervention Period
次要结局
未报告次要终点
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG