A dual-action, low-volume bowel cleanser administered the day before colonoscopy: Results from the SEE CLEAR II study

Philip O. Katz, Douglas Rex, Michael Epstein, Nav K. Grandhi, Stephen Vanner, Lawrence C. Hookey, Vivian Alderfer, Raymond E. Joseph

Research output: Contribution to journalArticle

61 Citations (Scopus)

Abstract

OBJECTIVES:Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.METHODS:This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).RESULTS:A total of 603 patients were randomized to receive either P/MC (n=300) or 2L PEG-3350 and bisacodyl tablets (n=303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0%) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7%). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1% of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0% vs. 4.3%), vomiting (1.4% vs. 2.0%), and headache (2.7% vs. 1.7%). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.CONCLUSIONS:When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.

Original languageEnglish
Pages (from-to)401-409
Number of pages9
JournalAmerican Journal of Gastroenterology
Volume108
Issue number3
DOIs
StatePublished - Mar 2013

Fingerprint

Bisacodyl
Colonoscopy
Tablets
Vital Signs
Sigmoid Colon
Safety
Physical Examination
Electrocardiography
Colon
magnesium citrate
polyethylene glycol 3350

ASJC Scopus subject areas

  • Gastroenterology

Cite this

A dual-action, low-volume bowel cleanser administered the day before colonoscopy : Results from the SEE CLEAR II study. / Katz, Philip O.; Rex, Douglas; Epstein, Michael; Grandhi, Nav K.; Vanner, Stephen; Hookey, Lawrence C.; Alderfer, Vivian; Joseph, Raymond E.

In: American Journal of Gastroenterology, Vol. 108, No. 3, 03.2013, p. 401-409.

Research output: Contribution to journalArticle

Katz, PO, Rex, D, Epstein, M, Grandhi, NK, Vanner, S, Hookey, LC, Alderfer, V & Joseph, RE 2013, 'A dual-action, low-volume bowel cleanser administered the day before colonoscopy: Results from the SEE CLEAR II study', American Journal of Gastroenterology, vol. 108, no. 3, pp. 401-409. https://doi.org/10.1038/ajg.2012.441
Katz, Philip O. ; Rex, Douglas ; Epstein, Michael ; Grandhi, Nav K. ; Vanner, Stephen ; Hookey, Lawrence C. ; Alderfer, Vivian ; Joseph, Raymond E. / A dual-action, low-volume bowel cleanser administered the day before colonoscopy : Results from the SEE CLEAR II study. In: American Journal of Gastroenterology. 2013 ; Vol. 108, No. 3. pp. 401-409.
@article{06f6660b25db47b7804c48846db7a40a,
title = "A dual-action, low-volume bowel cleanser administered the day before colonoscopy: Results from the SEE CLEAR II study",
abstract = "OBJECTIVES:Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.METHODS:This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).RESULTS:A total of 603 patients were randomized to receive either P/MC (n=300) or 2L PEG-3350 and bisacodyl tablets (n=303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0{\%}) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7{\%}). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1{\%} of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0{\%} vs. 4.3{\%}), vomiting (1.4{\%} vs. 2.0{\%}), and headache (2.7{\%} vs. 1.7{\%}). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.CONCLUSIONS:When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.",
author = "Katz, {Philip O.} and Douglas Rex and Michael Epstein and Grandhi, {Nav K.} and Stephen Vanner and Hookey, {Lawrence C.} and Vivian Alderfer and Joseph, {Raymond E.}",
year = "2013",
month = "3",
doi = "10.1038/ajg.2012.441",
language = "English",
volume = "108",
pages = "401--409",
journal = "American Journal of Gastroenterology",
issn = "0002-9270",
publisher = "Nature Publishing Group",
number = "3",

}

TY - JOUR

T1 - A dual-action, low-volume bowel cleanser administered the day before colonoscopy

T2 - Results from the SEE CLEAR II study

AU - Katz, Philip O.

AU - Rex, Douglas

AU - Epstein, Michael

AU - Grandhi, Nav K.

AU - Vanner, Stephen

AU - Hookey, Lawrence C.

AU - Alderfer, Vivian

AU - Joseph, Raymond E.

PY - 2013/3

Y1 - 2013/3

N2 - OBJECTIVES:Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.METHODS:This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).RESULTS:A total of 603 patients were randomized to receive either P/MC (n=300) or 2L PEG-3350 and bisacodyl tablets (n=303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0%) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7%). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1% of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0% vs. 4.3%), vomiting (1.4% vs. 2.0%), and headache (2.7% vs. 1.7%). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.CONCLUSIONS:When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.

AB - OBJECTIVES:Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.METHODS:This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).RESULTS:A total of 603 patients were randomized to receive either P/MC (n=300) or 2L PEG-3350 and bisacodyl tablets (n=303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0%) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7%). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1% of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0% vs. 4.3%), vomiting (1.4% vs. 2.0%), and headache (2.7% vs. 1.7%). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.CONCLUSIONS:When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.

UR - http://www.scopus.com/inward/record.url?scp=84875229768&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84875229768&partnerID=8YFLogxK

U2 - 10.1038/ajg.2012.441

DO - 10.1038/ajg.2012.441

M3 - Article

C2 - 23318484

AN - SCOPUS:84875229768

VL - 108

SP - 401

EP - 409

JO - American Journal of Gastroenterology

JF - American Journal of Gastroenterology

SN - 0002-9270

IS - 3

ER -