Achieving successful bowel preparation with evening/morning split-dosing regimens of NER1006 versus trisulfate: post hoc analysis of a Phase 3 trial

Authors: Michael Epstein, Pradeep Bekal

Effective colonoscopy requires effective bowel preparation. For detection of polyps larger than 5mm, an ‘adequate’ segmental cleansing level has recently been defined as score 2 or higher on the Boston Bowel Preparation Scale (BBPS) [1]. The NOCT Phase 3 randomized controlled trial reported cleansing rates as measured by the Harefield Cleansing Scale. During the trial, central readers also scored bowel cleanliness using the BBPS. This post hoc analysis reports the rate of cleansing success measured using the BBPS, for those patients who had a readable colonoscopy, comparing NER1006 to trisulfate (TS) solution.

In the NOCT trial [2], 621 patients aged 18–85 were randomized to bowel preparation using either NER1006 or TS via an evening/morning split-dosing regimen. Adequate level cleansing success was assessed according to the BBPS for both overall- (all segments ≥2) and right colon cleansing (segmental score ≥2). The analysis included all subjects for whom colonoscopy videos were transmitted and assessed by central readers. Central readers were blinded to the administered treatment.

Data from 515 patients were analysed. When using evening/morning split-dosing, 228/255 (89.4%) patients treated with NER1006 achieved adequate level overall colon cleansing compared to 227/260 (87.3%) treated with TS (Table 1). Similarly, 240/255 (94.1%) patients treated with NER1006 achieved adequate level right colon cleansing compared to 236/260 (90.8%) treated with TS. The difference between the groups was not statistically significant, however, there was a numerical advantage in favour of NER1006 for the proportion of patients achieving both adequate overall colon cleansing success and adequate cleansing success in the right colon.

When used as an evening/morning split-dosing regimen, both NER1006 and TS delivered a consistent and very high level of adequate level cleansing success for both the overall colon and the right colon. In the right colon a numerically higher cleansing rate was seen for NER1006 versus TS when measured using the BBPS, however, the difference did not reach statistical significance.

  1. Clark BT et al. Gastroenterology 2016; 150(2): 396–405
  2. DeMicco M et al. United European Gastroenterology J 2016; 4(5S): A1–A156. OP375