drugset

drugset / Trial / NCT02751411

Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

NCT02751411 ↗

Phase 4 Completed 158 enrolled Aboca Ceinge - Biotecnologie Avanzate s.c. a r.l. · collab Eclisse - Euromed Clinical Supply Services Srl · collab Latis S.r.l. · collab PhAST Consulting Srl · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-

Timeline

Start: 2016-04-18
Primary completion: 2019-12-31
Completion: 2020-03-17

Publications

Strisciuglio C, Coppola V, Russo M, Tolone C, Marseglia GL, Verrotti A, Caimmi S, Caloisi C, D'Argenio V, Sacchetti L, Staiano A. Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial. Front Pediatr. 2021 Oct 29;9:753938. doi: 10.3389/fped.2021.753938. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	PEG 4000	Unknown	—	Oral

Indications