Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults.

Summary

This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen. Approximately 484 patients will be randomised with the aim of achieving a minimum of 220 patients in each of the 2 groups.

Timeline

Start

2014-11

Primary completion

2015-08

Completion

2015-08

Outcome

Missed primary endpoint

registry analysis (non-inferiority or equivalence test); SP+MS, Day Before-Only Dosing vs NER1006, Day Before-Only Dosing; p = 0.038; NCT02273141 ↗

registry analysis (non-inferiority or equivalence test); SP+MS, Day Before-Only Dosing vs NER1006, Day Before-Only Dosing; p = 0.027; NCT02273141 ↗

Publications

• Cash BD, Allen C, Poppers DM. Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials. BMC Gastroenterol. 2022 Sep 5;22(1):412. doi: 10.1186/s12876-022-02484-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Magnesium Salt	Unknown	—	—
Subject	Polyethylene Glycol 3350	Other / unclassified	—	—
Comparator	Sodium Picosulfate	Unknown	—	—

Indications