Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study - 30/06/13
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.
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, CI, ECG, ITT, P/MC, PP, SAE, TEAE, 2L PEG-3350
Plan
| DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: Dr Rex has received grant/research support from, participated in speakers' bureaus of, and/or acted as a consultant for Ferring Pharmaceuticals, Inc and Braintree Laboratories. Dr Katz has received grant/research support from, participated in speakers' bureaus of, and/or acted as a consultant for Intec Pharma, Ironwood, Novartis Consumer, and Takeda. Dr Bertiger has acted as a consultant for Ferring Pharmaceuticals, Inc. Dr Vanner has received grant/research support from, participated in speakers' bureaus of, and/or acted as a consultant for Ferring Pharmaceuticals, Inc in Canada and the United States. Dr Hookey has received grant/research support from Ferring Pharmaceuticals, Inc in Canada and has participated in speakers' bureaus of and/or acted as a consultant for Ferring Pharmaceuticals, Inc in Canada and the United States. Dr Alderfer is an employee of ICON Clinical Research, the organization contracted on behalf of Ferring Pharmaceuticals, Inc to maintain the database and perform statistical analyses for the study. Dr Joseph is a full-time employee of Ferring Pharmaceuticals, Inc. Funding for data analysis and manuscript development was provided by Ferring Pharmaceuticals, Inc. |
Vol 78 - N° 1
P. 132-141 - juillet 2013 Retour au numéro
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