Lubiprostone in Children With Functional Constipation

NCT02042183 ↗

Phase 3 Completed 606 enrolled Sucampo Pharma Americas, LLC Sucampo AG · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Timeline

Start: 2013-12-13
Primary completion: 2016-07-27
Completion: 2016-07-27

Outcome

Missed primary endpoint

registry Lubiprostone vs Placebo; p = 0.1609 NCT02042183 ↗

paper No statistically significant difference in overall SBM response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P = .2245). PMID 33838349 ↗

Publications

Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lubiprostone	Small molecule	12 ug	Oral
Subject	Lubiprostone	Small molecule	24 ug	Oral