Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity

Phase 4 Completed 13 enrolled Shire

RandomizedCrossoverOpen-labelTreatment

Summary

To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.

Timeline

Start: 2013-02-27
Primary completion: 2013-11-27
Completion: 2013-11-27

Outcome

Met primary endpoint

registry analysis (unspecified test); Prucalopride vs PEG 3350; p = 0.012; Mean Difference (Final Values) 5.8 (95% CI 1.6 to 9.9); Linear Mixed-Effect Models Analysis NCT01707667 ↗

Publications

Miner PB Jr, Camilleri M, Burton D, Achenbach H, Wan H, Dragone J, Mellgard B. Prucalopride induces high-amplitude propagating contractions in the colon of patients with chronic constipation: a randomized study. Neurogastroenterol Motil. 2016 Sep;28(9):1341-8. doi: 10.1111/nmo.12832. Epub 2016 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Polyethylene Glycol 3350	Other / unclassified	13.8 g	Oral
Subject	Prucalopride	Small molecule	2 mg	Oral