2022-501946-31-00招募中3 期
A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, with Functional Constipation (FC) with a 24-week Open-label Treatment Extension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 7
- 主要终点
- Change from baseline in 12-week SBM frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.
研究概览
简要总结
Part 1: to evaluate the safety and efficacy of 12 weeks of linaclotide therapy in comparison with placebo in pediatric subjects aged 2 to 5 years who meet modified Rome IV criteria for childhood FC. Part 2: to assess the long-term safety of linaclotide administered to subjects with pediatric FC who have completed study intervention in Part 1 of this study or completed Study LIN-MD-67.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Part 2
- 盲法
- None
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
- •Subjects must be ages 24 months to 5 years and 11 months (inclusive) at the time the caregiver/parent/guardian/LAR has provided signed consent in alignment with local requirements.
- •Subject does not have any condition or clinically significant findings on a physical examination, vital sign assessment, ECG, or clinical laboratory tests at Screening (Visit 1), as determined by the investigator, based on consideration of whether the finding could represent a safety concern or a condition that would be exclusionary, could prevent the subject from performing any protocol assessments, or could confound study assessments.
- •Subject meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), the subject has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) per week.
- •Caregiver/parent/guardian/LAR is willing to discontinue any laxatives used before the Preintervention Visit (Visit 2) in favor of the protocol-permitted rescue medicine.
- •Based on the eDiary, the subject has an average ≤ 2 SBMs per week during the 14 days before the randomization day and up to the randomization (including the eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). An SBM is defined as a 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 history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- •Subjects with condition 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 history of known or suspected mechanical bowel obstruction or pseudo-obstruction.
- •Subject did not use a protocol-specified prohibited medicine before the start of the Preintervention Period 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 the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- •Subject must not have any planned or ongoing toilet training at any time in Part
- •Subjects may start toilet training at any time during Part
- •Toilet training is defined as the process of training a child to recognize their body signals for the need to urinate and/or have a bowel movement, to control the urination and/or bowel movement and to use the toilet. Children who are fully toilet trained or who have not yet started the process are eligible to participate.
结局指标
主要结局
Change from baseline in 12-week SBM frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.
Change from baseline in 12-week SBM frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.
次要结局
- Change from baseline in 12-week stool consistency observed by the primary caregiver during the double-blind study intervention period
- Change from baseline in 12-week straining observed by the primary caregiver during the double-blind study intervention period
- Change from baseline in 12-week proportion of days with fecal incontinence during the double-blind study intervention period (for subjects who have acquired toileting skills during daytime and nighttime or acquired toileting skills during daytime only)
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
研究点 (7)
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