PMID- 23566639
OWN - NLM
STAT- MEDLINE
DCOM- 20140225
LR  - 20220408
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 78
IP  - 1
DP  - 2013 Jul
TI  - Split-dose administration of a dual-action, low-volume bowel cleanser for 
      colonoscopy: the SEE CLEAR I study.
PG  - 132-41
LID - S0016-5107(13)00184-3 [pii]
LID - 10.1016/j.gie.2013.02.024 [doi]
AB  - BACKGROUND: New bowel cleansers for colonoscopy that lead to improved efficacy, 
      safety, and tolerability are needed. OBJECTIVE: This study evaluated a 
      nonphosphate, dual-action, low-volume, orange-flavored preparation containing 
      sodium picosulfate and magnesium citrate (P/MC). DESIGN: Multicenter, 
      assessor-blinded, randomized, noninferiority study. SETTING: University 
      hospitals, academic medical centers, and private clinics across the United 
      States. PATIENTS: Adults preparing for colonoscopy. INTERVENTIONS: P/MC versus 2 
      L of polyethylene glycol solution (2L PEG-3350) and two 5-mg bisacodyl tablets. 
      MAIN OUTCOME MEASUREMENTS: This phase 3 study investigated the efficacy, safety, 
      and tolerability of split-dose administration of P/MC versus day-before dosing of 
      2L PEG-3350 and two 5-mg bisacodyl tablets (SEE CLEAR I study). Efficacy was 
      evaluated by using the Aronchick and Ottawa scales; noninferiority and 
      superiority analyses were performed. Safety was assessed by monitoring adverse 
      events (AEs). Tolerability was measured via a patient questionnaire. RESULTS: The 
      intent-to-treat population consisted of 601 patients who self-administered P/MC 
      (n = 304) or 2L PEG-3350 and bisacodyl tablets (n = 297). P/MC was superior to 2L 
      PEG-3350 and bisacodyl tablets in overall colon cleansing (84.2% vs 74.4%; 
      1-sided 97.5% confidence interval [CI], 3.4) (Aronchick scores of excellent or 
      good) and in cleansing of the ascending (89.5% vs 78.8%; 1-sided 97.5% CI, 4.9), 
      mid (transverse and descending) (92.4% vs 85.9%; 1-sided 97.5% CI, 1.6), and 
      rectosigmoid (92.4% vs 87.2%; 1-sided 97.5% CI, 0.4) segments of the colon 
      (Ottawa scores of excellent, good, or fair). Commonly reported AEs related to the 
      bowel preparations were nausea, vomiting, headache, and chills. Patient-reported 
      tolerability, including ease of consumption and taste, was significantly higher 
      for P/MC than 2L PEG-3350 and bisacodyl tablets (P < .0001). LIMITATIONS: Because 
      of differences in administration and volume of the bowel preparations, the study 
      was designed to be a single-assessor, blinded study. CONCLUSIONS: The 
      bowel-cleansing effects and patient acceptability of split-dose P/MC were 
      superior to day-before dosing with 2L PEG-3350 and bisacodyl tablets.
CI  - Copyright (c) 2013 American Society for Gastrointestinal Endoscopy. Published by 
      Mosby, Inc. All rights reserved.
FAU - Rex, Douglas K
AU  - Rex DK
AD  - Indiana University School of Medicine, Indianapolis, Indiana, USA.
FAU - Katz, Philip O
AU  - Katz PO
FAU - Bertiger, Gerald
AU  - Bertiger G
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 - 20130406
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Cathartics)
RN  - 0 (Citrates)
RN  - 0 (Organometallic Compounds)
RN  - 0 (Picolines)
RN  - 0 (Tablets)
RN  - 10X0709Y6I (Bisacodyl)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 7487-88-9 (Magnesium Sulfate)
RN  - LR57574HN8 (picosulfate sodium)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Bisacodyl/*pharmacology
MH  - Cathartics/*pharmacology
MH  - Citrates/*pharmacology
MH  - Colorectal Neoplasms/diagnosis
MH  - Confidence Intervals
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Magnesium Sulfate/*pharmacology
MH  - Male
MH  - Middle Aged
MH  - Organometallic Compounds/*pharmacology
MH  - Patient Satisfaction
MH  - Picolines/*pharmacology
MH  - Polyethylene Glycols/*pharmacology
MH  - Single-Blind Method
MH  - Statistics, Nonparametric
MH  - Tablets
MH  - Therapeutic Irrigation/methods
MH  - Young Adult
EDAT- 2013/04/10 06:00
MHDA- 2014/02/26 06:00
CRDT- 2013/04/10 06:00
PHST- 2012/12/12 00:00 [received]
PHST- 2013/02/20 00:00 [accepted]
PHST- 2013/04/10 06:00 [entrez]
PHST- 2013/04/10 06:00 [pubmed]
PHST- 2014/02/26 06:00 [medline]
AID - S0016-5107(13)00184-3 [pii]
AID - 10.1016/j.gie.2013.02.024 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2013 Jul;78(1):132-41. doi: 10.1016/j.gie.2013.02.024. Epub 
      2013 Apr 6.