Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable B… (NCT04026113) | Clinical Trial Compass
CompletedPhase 3
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
United States438 participantsStarted 2019-10-01
Plain-language summary
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.
Who can participate
Age range6 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Improvement with defecation;
✓. Onset associated with a change in frequency of stool;
✓. Onset associated with a change in form (appearance) of stool;
Exclusion criteria
✕. Improvement with defecation
✕. Onset associated with a change in frequency of stool
✕. Onset associated with a change in form (appearance) of stool;
✕. Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
✕. Cystic fibrosis;
✕. Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
✕. Down's syndrome or any other chromosomal disorder;
What they're measuring
1
Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period
Timeframe: Baseline, up to 12 weeks
2
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate