PMID- 23318484
OWN - NLM
STAT- MEDLINE
DCOM- 20130520
LR  - 20220408
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 108
IP  - 3
DP  - 2013 Mar
TI  - A dual-action, low-volume bowel cleanser administered the day before colonoscopy: 
      results from the SEE CLEAR II study.
PG  - 401-9
LID - 10.1038/ajg.2012.441 [doi]
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.
FAU - Katz, Philip O
AU  - Katz PO
AD  - Albert Einstein Healthcare Network, Philadelphia, Pennsylvania 19141, USA. 
      katzp@einstein.edu
FAU - Rex, Douglas K
AU  - Rex DK
FAU - Epstein, Michael
AU  - Epstein M
FAU - Grandhi, Nav K
AU  - Grandhi NK
FAU - Vanner, Stephen
AU  - Vanner S
FAU - Hookey, Lawrence C
AU  - Hookey LC
FAU - Alderfer, Vivian
AU  - Alderfer V
FAU - Joseph, Raymond E
AU  - Joseph RE
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130115
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Cathartics)
RN  - 0 (Citrates)
RN  - 0 (Organometallic Compounds)
RN  - 0 (Picolines)
RN  - 10X0709Y6I (Bisacodyl)
RN  - 2968PHW8QP (Citric Acid)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - LR57574HN8 (picosulfate sodium)
RN  - RHO26O1T9V (magnesium citrate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Bisacodyl/administration & dosage/*therapeutic use
MH  - Cathartics/administration & dosage/*therapeutic use
MH  - Citrates/administration & dosage/*therapeutic use
MH  - Citric Acid/administration & dosage/*therapeutic use
MH  - Colon/drug effects
MH  - Colonoscopy/*methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Organometallic Compounds/administration & dosage/*therapeutic use
MH  - Patient Satisfaction
MH  - Picolines/administration & dosage/*therapeutic use
MH  - Polyethylene Glycols/administration & dosage/*therapeutic use
MH  - Surveys and Questionnaires
EDAT- 2013/01/16 06:00
MHDA- 2013/05/22 06:00
CRDT- 2013/01/16 06:00
PHST- 2013/01/16 06:00 [entrez]
PHST- 2013/01/16 06:00 [pubmed]
PHST- 2013/05/22 06:00 [medline]
AID - ajg2012441 [pii]
AID - 10.1038/ajg.2012.441 [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2013 Mar;108(3):401-9. doi: 10.1038/ajg.2012.441. Epub 2013 
      Jan 15.