Linaclotide and Functional Constipation (LIN-MD-64)
This study is interested in exploring if linaclotide is a safe and reliable treatment option for children diagnosed with functional constipation. Research participants will be randomized in a 1:1 ratio to receive oral administration of linaclotide capsules or placebo over the ...
About
Protocol Description
This is a double-blind, multicenter, prospective, randomized, parallel-group, placebo-controlled study that will assess the safety and efficacy of linaclotide vs. placebo in children, aged 6 to 17, with a diagnosis of functional constipation. Following informed consent and screening for eligibility, participants will be randomized in a 1:1 ratio to receive a daily dose of linaclotide or placebo. Participants will take linaclotide or placebo orally, and over the course of a study intervention period lasting 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Children between ages of 6 to 17
- Must meet modified Rome III criteria for child/adolescent functional constipation
- Must comply with completion of eDiary entries
- Able to read and understand assessments in eDiary device
Exclusion Criteria
- History of non-retentive fecal incontinence
- Meets modified Rome III criteria for child/adolescent irritable bowel syndrome
- Presence of mechanical bowel obstruction or pseudo-obstruction
- Has unexplained and clinically significant alarm symptoms (lower GI bleeding iron-deficiency anemia, any unexplained anemia, or weight loss), systemic signs of infection or colitis, or any neoplastic process
Primary Investigator
Director of Pediatric Inflammatory Bowel Disease Program at Carilion Children’s. In addition, Dr. Garin-Laflam holds an academic appointment as Associate Professor of Pediatrics with the Virginia Tech Carilion School of Medicine.
Contact Information
Cyrus A. Legard, M.P.H.
Clinical Research Coordinator
