Gastroenterology · Phase 3
Linaclotide: pediatric functional constipation
What was tested?
Linaclotide versus placebo in the functional-constipation cohort of a pediatric trial. ↗
Registered primary question: For functional constipation, change in weekly spontaneous bowel-movement frequency over 12 weeks; the registry has a separate primary endpoint for its IBS-C cohort. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
The adjusted between-group difference was 1.17 additional spontaneous bowel movements per week. Diarrhea occurred in seven of 164 active-group and three of 164 placebo participants; one active-group participant required hospitalization for dehydration.↗
Keep in context: The registry covers 438 participants across two conditions. This report concerns 330 randomized children with functional constipation, of whom 328 received treatment. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 438 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 6 Years to 17 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2024-11-26; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Pediatric functional constipation
- Design in the report
- Randomized, double-blind, placebo-controlled phase 3 trial lasting 12 weeks.↗
- Participants in the report
- 330 children aged 6–17 years were randomized; 328 received treatment and 293 completed.↗
- Limitations
- The trial addresses functional constipation in the enrolled age range. Its findings cannot establish safety in younger children or replace age-specific label warnings.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
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) ↗
Protocol identifier: LIN-MD-64. Sponsor: AbbVie.
Retrieved 2026-09-20; SHA-256 20846803dd369ce508bf0864b16a37d7c828f0234a8365c2974afc9e5f5c6af0.
PMID 38211604
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 38211604. SHA-256 f2177628b98083064df17512c3dd229b760887c00cc64c4cfa4fc4e49523b12a.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 58b2d55045c664eb19aec9f97374ea3268f561017615f37584eb189d4c41c982.