Functional Constipation: 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

Phase 1

• Conditions: Functional Constipation (FC); MedDRA version: 20.0Level: PTClassification code: 10010774Term: Constipation Class: 100000004856; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2022-501947-34-00
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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 a weight to height ratio of = 2nd percentile for age at the time the LAR/parent/guardian has provided signed consent, Subject meets modified 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 volitional 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 fewer than 2 small bowl 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified