Endoscopy 2018; 50(04): S88
DOI: 10.1055/s-0038-1637289
ESGE Days 2018 oral presentations
21.04.2018 – Colon cleansing
Georg Thieme Verlag KG Stuttgart · New York

HIGHER MEAN HAREFIELD CLEANSING SCALE SCORES WITH 1L PEG-BASED NER1006 VERSUS 2L PEG + ASCORBATE: POST HOC ANALYSIS OF A RANDOMISED PHASE 3 CLINICAL TRIAL

, MORA Study Group
R Bisschops
1   KU Leuven, University Hospitals Leuven, Leuven, Belgium
,
J Manning
2   Borders General Hospital, Melrose, Berwickshire, United Kingdom
,
L Clayton
3   Norgine, Clinical Development, Harefield, United Kingdom
,
B Amlani
4   Norgine, Medical Affairs, Harefield, United Kingdom
,
M Álvarez-González
5   Hospital del Mar, Barcelona, Spain
› Author Affiliations
Further Information

Publication History

Publication Date:
27 March 2018 (online)

Also available at
 

Aims:

The cleansing efficacy and safety of NER1006 (PLENVU®), a novel 1L polyethylene glycol (PEG)-based bowel preparation, were assessed versus standard 2L PEG + Ascorbate in the randomised phase 3 clinical trial MORA. This post hoc analysis of MORA assessed cleansing efficacy as the mean segmental cleansing scores using the Harefield Cleansing Scale (HCS).

Methods:

Patients (n = 849) aged 18 – 85 years were randomised to split-dosing bowel preparation with NER1006 evening/morning (NER1006 PM/AM), NER1006 morning only (NER1006 AM/AM), or 2L PEG + ascorbate (2L PEG + Ascorbate PM/AM).

Cleansing quality was assessed by treatment-blinded central readers using the HCS and scored 0 – 4 in each of the five HCS colon segments. Mean scores were calculated.

Results:

792 patients were analysed (Table 1). In all five segments, NER1006 PM/AM attained higher mean segmental HCS scores than 2L PEG + Ascorbate PM/AM (2.4 vs. 2.1, P < 0.0001; 2.6 vs. 2.3 vs. P < 0.0001; 2.6 vs. 2.4, P = 0.0006; 2.80 vs. 2.6, P = 0.0071; and 3.1 vs. 2.8, P < 0.0001). NER1006 AM/AM achieved higher mean segmental scores in the ascending colon plus caecum, transverse colon, descending colon, and rectum (2.4 vs. 2.1, P < 0.0001; 2.5 vs. 2.3, P < 0.0001; 2.6 vs. 2.4, P < 0.0001; 2.9 vs. 2.8, P = 0.0293).

Tab. 1:

Mean Harefield Cleansing Scale scores

HCS cleansing scores, mean (SD) [P-value vs. 2L PEG + Ascorbate PM/AM]

NER1006 PM/AM, N = 262

NER1006 AM/AM, N = 270

2L PEG + Ascorbate PM/AM, N = 260

HCS Ascending colon

2.4 (0.74) [P < 0.0001]

2.4 (0.79) [P < 0.0001]

2.1 (0.70)

HCS Transverse colon

2.6 (0.73) [P < 0.0001]

2.5 (0.83) [P < 0.0001]

2.3 (0.73)

HCS Descending colon

2.6 (0.78) [P = 0.0006]

2.6 (0.83) [P < 0.0001]

2.4 (0.75)

HCS Sigmoid colon

2.8 (0.87) [P = 0.0071]

2.7 (0.93) [P = 0.0892

2.6 (0.88)

HCS Rectum

3.1 (0.86) [P < 0.0001

2.9 (0.93) [P = 0.0293]

2.8 (0.90)

Conclusions:

Both NER1006 dosing regimens, NER1006 PM/AM and NER1006 AM/AM, are more effective bowel preparations than 2L PEG + Ascorbate. NER1006 is the first low volume bowel preparation to demonstrate higher cleansing efficacy than standard 2L PEG + Ascorbate.