Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: The SEE CLEAR i study

Douglas K. Rex, Philip O. Katz, Gerald Bertiger, Stephen Vanner, Lawrence C. Hookey, Vivian Alderfer, Raymond E. Joseph

Research output: Contribution to journalArticle

55 Scopus citations

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). 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.

Original languageEnglish (US)
Pages (from-to)132-141
Number of pages10
JournalGastrointestinal endoscopy
Volume78
Issue number1
DOIs
StatePublished - Jul 1 2013

Keywords

  • 2 L of polyethylene glycol solution
  • 2L PEG-3350
  • adverse event
  • AE
  • CI
  • confidence interval
  • ECG
  • electrocardiogram
  • intent to treat
  • ITT
  • P/MC
  • per-protocol
  • PP
  • SAE
  • serious adverse event
  • sodium picosulfate and magnesium citrate
  • TEAE
  • treatment-emergent adverse event

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

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    Rex, D. K., Katz, P. O., Bertiger, G., Vanner, S., Hookey, L. C., Alderfer, V., & Joseph, R. E. (2013). Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: The SEE CLEAR i study. Gastrointestinal endoscopy, 78(1), 132-141. https://doi.org/10.1016/j.gie.2013.02.024