A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY

Phase 2 Completed 46 enrolled Dark Canyon Laboratories, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this Phase 2 Study was to compare the safety of 3 liter(L) and 4 liter(L) split dose DCL-101 to split dose 4L GoLYTELY in patients preparing for colonoscopy, with secondary objectives to assess tolerability and bowel cleansing efficacy.

Timeline

Start: 2017-01
Primary completion: 2017-11
Completion: 2017-11

Publications

Bachwich DR, Lewis JD, Kowal VO, Jacobson BC, Calderwood AH, Kochman ML. A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, vs 4L Polyethylene Glycol-Electrolyte Solution. Clin Transl Gastroenterol. 2020 Dec;11(12):e00264. doi: 10.14309/ctg.0000000000000264.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DCL-101	Unknown	3000 ml	Oral
Subject	DCL-101	Unknown	4000 ml	Oral
Subject	polyethylene glycol	Other / unclassified	4000 ml	Oral

Indications

No indication recorded.