Linaclotide and IBS-C
This study is interested in exploring if linaclotide is a safe and reliable treatment option for children diagnosed with irritable bowel syndrome with constipation (IBS-C). Research participants will be randomized i...
About
Protocol Description
A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide in Pediatric Participants, Ages 6 to 17 Years, With Irritable Bowel Syndrome with Constipation (IBS-C) and of Linaclotide versus Placebo in Pediatric Participants with Functional Constipation (FC)
This is a double-blind, multicenter, prospective, randomized, parallel-group, placebo-controlled study that will assess the safety and efficacy of linaclotide in children, aged 6 to 17, with a diagnosis of irritable bowel syndrome with constipation (IBS-C). Following informed consent and screening for eligibility, participants will be randomized in a 1:1 ratio to receive a daily dose of 145 micrograms or 290 micrograms of linaclotide. Participants will take linaclotide 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 and irritable bowel syndrome with 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
- Participant used a protocol-specified prohibited medicine before the start of the Preintervention Period or failed to meet the stable-dose requirements of certain medications.
- Requires manual disimpaction at any point before randomization
- 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
Dr. Garin-Laflam is a pediatric gastroenterologist with Carilion Clinic and concurrently holds an academic appointment as Associate Professor of Pediatrics with Virginia Tech Carilion School of Medicine. Dr. Garin-Laflam’s clinical interests revolve around clinical trials, quality improvement, inflammatory bowel disease, and treatment of other gastrointestinal illnesses in children.
Contact Information
Cyrus Legard, MPH
Clinical Research Coordinator
