Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension.
Clin Gastroenterol Hepatol
; 20(3): 602-610.e5, 2022 03.
Article
en En
| MEDLINE
| ID: mdl-33838349
ABSTRACT
BACKGROUND & AIMS:
Pediatric functional constipation (PFC) is a common problem in children that causes distress and presents treatment challenges to health care professionals. We conducted a randomized, placebo-controlled trial (study 1) in patients with PFC (6-17 years of age) to evaluate the efficacy and safety of lubiprostone, followed by an open-label extension for those who completed the placebo-controlled phase (study 2).METHODS:
Study 1 (NCT02042183) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 12-week study evaluating the efficacy and safety of lubiprostone 12 µg twice daily (BID) and 24 µg BID. Study 2 (NCT02138136) was a phase 3, long-term, open-label extension of study 1. In both studies, lubiprostone doses were based on patients' weight. Efficacy was assessed solely based on study 1, with a primary endpoint of overall spontaneous bowel movement (SBM) response (increase of ≥1 SBM/wk vs baseline and ≥3 SBMs/wk for ≥9 weeks, including 3 of the final 4 weeks).RESULTS:
606 patients were randomized to treatment (placebo n = 202; lubiprostone n = 404) in study 1. No statistically significant difference in overall SBM response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P = .2245). Both the 12-µg BID and 24-µg BID doses of lubiprostone were well tolerated in the double-blind and extension phases, with a safety profile consistent with that seen in adult studies.CONCLUSIONS:
Lubiprostone did not demonstrate statistically significant effectiveness over placebo in children and adolescents with PFC but did demonstrate a safety profile similar to that in adults. (ClinicalTrials.gov Number NCT02042183; Number NCT02138136).Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Estreñimiento
/
Defecación
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Clin Gastroenterol Hepatol
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2022
Tipo del documento:
Article