title: Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study.
abstract: 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).
  
  
  METHODS
  Multicenter, assessor-blinded, randomized, noninferiority study.
  
  
  METHODS
  University hospitals, academic medical centers, and private clinics across the United States.
  
  
  METHODS
  Adults preparing for colonoscopy.
  
  
  METHODS
  P/MC versus 2 L of polyethylene glycol solution (2L PEG-3350) and two 5-mg bisacodyl tablets.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Douglas K
authors.initials: DK
authors.lastname: Rex
authors.forename: Philip O
authors.initials: PO
authors.lastname: Katz
authors.forename: Gerald
authors.initials: G
authors.lastname: Bertiger
authors.forename: Stephen
authors.initials: S
authors.lastname: Vanner
authors.forename: Lawrence C
authors.initials: LC
authors.lastname: Hookey
authors.forename: Vivian
authors.initials: V
authors.lastname: Alderfer
authors.forename: Raymond E
authors.initials: RE
authors.lastname: Joseph
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001726:Bisacodyl / Q000494:pharmacology*; D002400:Cathartics / Q000494:pharmacology*; D002951:Citrates / Q000494:pharmacology*; D015179:Colorectal Neoplasms / Q000175:diagnosis; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008278:Magnesium Sulfate / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000494:pharmacology*; D017060:Patient Satisfaction; D010847:Picolines / Q000494:pharmacology*; D011092:Polyethylene Glycols / Q000494:pharmacology*; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D013607:Tablets; D007507:Therapeutic Irrigation / Q000379:methods; D055815:Young Adult
chemical_list: D002400:Cathartics; D002951:Citrates; D009942:Organometallic Compounds; D010847:Picolines; D013607:Tablets; D001726:Bisacodyl; D011092:Polyethylene Glycols; D008278:Magnesium Sulfate; C005701:picosulfate sodium