Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial.
Ascorbic Acid
/ pharmacology
Cathartics
/ administration & dosage
Citrates
/ pharmacology
Citric Acid
/ pharmacology
Colon
/ diagnostic imaging
Colonoscopy
/ methods
Drug Monitoring
/ methods
Europe
Female
Humans
Male
Middle Aged
Organometallic Compounds
/ pharmacology
Patient Compliance
Patient Preference
Picolines
/ pharmacology
Polyethylene Glycols
/ pharmacology
Preoperative Care
/ methods
Treatment Outcome
Journal
Endoscopy
ISSN: 1438-8812
Titre abrégé: Endoscopy
Pays: Germany
ID NLM: 0215166
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
pubmed:
20
7
2018
medline:
30
8
2019
entrez:
20
7
2018
Statut:
ppublish
Résumé
Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing. Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SP + MC. Cleansing was assessed on the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS) using central readers. Two primary end points were assessed: overall colon cleansing success and high-quality cleansing of the right colon. Intention-to-treat (modified full analysis set [mFAS]) and per protocol (PP) analyses were performed. Of 515 patients, efficacy was analyzed in 501 (NER1006, n = 250; SP + MC, n = 251) and 379 patients (NER1006, n = 172; SP + MC, n = 207) in the mFAS and PP analyses, respectively. Non-inferiority of NER1006 vs. SP + MC was established in the mFAS for both overall cleansing (62.0 % vs. 53.8 %; Colon cleansing with NER1006 vs. SP + MC was non-inferior (mFAS) and superior (PP), with acceptable safety.European Clinical Trials Database (EudraCT)2014-002186-30TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 study 2014-002186-30 at https://eudract.ema.europa.eu/.
Sections du résumé
BACKGROUND
Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing.
METHODS
Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SP + MC. Cleansing was assessed on the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS) using central readers. Two primary end points were assessed: overall colon cleansing success and high-quality cleansing of the right colon. Intention-to-treat (modified full analysis set [mFAS]) and per protocol (PP) analyses were performed.
RESULTS
Of 515 patients, efficacy was analyzed in 501 (NER1006, n = 250; SP + MC, n = 251) and 379 patients (NER1006, n = 172; SP + MC, n = 207) in the mFAS and PP analyses, respectively. Non-inferiority of NER1006 vs. SP + MC was established in the mFAS for both overall cleansing (62.0 % vs. 53.8 %;
CONCLUSIONS
Colon cleansing with NER1006 vs. SP + MC was non-inferior (mFAS) and superior (PP), with acceptable safety.European Clinical Trials Database (EudraCT)2014-002186-30TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 study 2014-002186-30 at https://eudract.ema.europa.eu/.
Substances chimiques
Cathartics
0
Citrates
0
Organometallic Compounds
0
Picolines
0
Citric Acid
2968PHW8QP
Polyethylene Glycols
3WJQ0SDW1A
picosulfate sodium
LR57574HN8
Ascorbic Acid
PQ6CK8PD0R
magnesium citrate
RHO26O1T9V
Types de publication
Clinical Trial
Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
73-84Commentaires et corrections
Type : CommentIn
Informations de copyright
© Georg Thieme Verlag KG Stuttgart · New York.
Déclaration de conflit d'intérêts
Rafał Filip and Cesare Hassan are DAYB investigators and each received funding from Norgine to attend an Investigators’ Meeting for the DAYB study; Lucy Clayton and Kerry Hylands are employees of Norgine but have no other conflicts of interest; the remaining authors are DAYB investigators but have no other conflicts of interest.