scholarly journals Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate

2018 ◽  
Vol 87 (3) ◽  
pp. 677-687.e3 ◽  
Author(s):  
Michael P. DeMicco ◽  
Lucy B. Clayton ◽  
Jeff Pilot ◽  
Michael S. Epstein ◽  
Pradeep Kumar T. Bekal ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Phase 3 ◽  
Colon Cleansing ◽  
Randomized Controlled

scholarly journals Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial

Endoscopy ◽  
2018 ◽  
Vol 51 (01) ◽  
pp. 60-72 ◽  
Author(s):  
Raf Bisschops ◽  
Jonathan Manning ◽  
Lucy Clayton ◽  
Richard Ng Kwet Shing ◽  
Marco Álvarez-González ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
High Volume ◽  
Polyp Detection ◽  
Right Colon ◽  
High Quality ◽  
Phase 3 ◽  
Total N ◽  
Colon Cleansing ◽  
Parallel Group

Abstract Background Polyethylene glycol (PEG)-based bowel preparations are effective cleansers but many require high-volume intake. This phase 3, randomized, blinded, multicenter, parallel-group, central reader-assessed study assessed the 1 L PEG NER1006 bowel preparation vs. standard 2 L PEG with ascorbate (2LPEG). Methods Patients undergoing colonoscopy were randomized (1:1:1) to receive NER1006, as an evening/morning (N2D) or morning-only (N1D) regimen, or evening/morning 2LPEG. Cleansing was assessed using the Harefield Cleansing Scale (HCS) and the Boston Bowel Preparation Scale (BBPS). Primary end points were overall bowel cleansing success and high-quality cleansing in the right colon. Modified full analysis set (mFAS) and per protocol (PP) analyses were performed. Mean cleansing scores were analyzed post hoc. Results Of 849 randomized patients, efficacy was analyzed in the following patient numbers (mFAS/PP): total n = 822/670; N2D n = 275/220; N1D n = 275/218; 2LPEG n = 272/232. mFAS established noninferiority. PP showed superiority for N2D on overall success (97.3 % vs. 92.2 %; P = 0.014), and for N2D and N1D on right colon high-quality cleansing (N2D 32.3 % vs. 15.9 %, P < 0.001; N1D 34.4 % vs. 15.9 %, P < 0.001) vs. 2LPEG. Using HCS, N2D and N1D attained superior segmental high-quality cleansing (P ≤ 0.003 per segment). N2D showed superior mean segmental HCS scores (P ≤ 0.007 per segment). Both N2D and N1D achieved superior mean overall (P < 0.001 and P = 0.006) and right colon BBPS scores (P < 0.001 and P = 0.013). N2D demonstrated superior right colon polyp detection (P = 0.024). Adherence, tolerability, and safety were comparable between treatments. Conclusions NER1006 is the first low-volume preparation to demonstrate superior colon cleansing efficacy vs. standard 2LPEG with ascorbate, with comparable safety and tolerability. European Clinical Trials Database (EudraCT)2014-002185-78TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 trial 2014-002185-78 at https://eudract.ema.europa.eu/

S1383: Split-Dose Polyethylene Glycol for Bowel Preparation Prior to Colonoscopy: A Meta-Analysis of Randomized Controlled Trials

2010 ◽  
Vol 71 (5) ◽  
pp. AB147
Author(s):  
Todd W. Kilgore ◽  
Nicholas M. Szary ◽  
Abhishek Choudhary ◽  
Michelle L. Matteson ◽  
John B. Marshall ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Randomized Controlled Trials ◽  
Bowel Preparation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Split Dose ◽  
Randomized Controlled

Efficacy of Prokinetics with a Split-Dose of Polyethylene Glycol in Bowel Preparation for Morning Colonoscopy: A Randomized Controlled Trial

Digestion ◽  
2012 ◽  
Vol 86 (3) ◽  
pp. 194-200 ◽  
Author(s):  
Hyoung Jun Kim ◽  
Tae Oh Kim ◽  
Bong Chul Shin ◽  
Jae Gon Woo ◽  
Eun Hee Seo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Split Dose ◽  
Randomized Controlled

scholarly journals P182 Bowel Preparation in inflammatory bowel diseases (IBD): preliminary results from a randomised trial evaluating efficacy, tolerability and safety of cleansing solutions in IBD patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S229-S230
Author(s):  
J L Rueda Garcia ◽  
C Suárez Ferrer ◽  
E Martín-Arranz ◽  
J Poza ◽  
M Sánchez-Azofra ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Past History ◽  
Statistical Significance ◽  
Randomised Trial ◽  
Laboratory Evaluation ◽  
P Value ◽  
Colon Cleansing ◽  
Inflammatory Bowel

Abstract Background Colonoscopy is the first-line procedure for the diagnosis and management of inflammatory bowel disease (IBD). Data regarding bowel preparation in patients with IBD are scarce. Our aim was to evaluate efficacy, safety and tolerability of the main available colon cleansing formulations in IBD patients: sodium picosulfate with magnesium citrate (SM+MC), 2L polyethylene glycol-ascorbate (2L-PEG-a) and 1L polyethylene glycol-ascorbate (1L-PEG-a). Methods Study design: Phase 4, randomised, single-centre, prescriber and colonoscopist-blinded study. EudraCT Number 2018-001402-28. Patients: IBD patients aged over 18 requiring colonoscopy. Exclusion criteria: pregnant women, past history of bowel resection, severe acute IBD flare or low-quality cleansing score in a colonoscopy performed 12 months prior to enrolment. Patients were randomized 1:1:1 to receive 1L PEG-a, 2L PEG-a or SP+MC; all preparations were administered in a split-dose regimen. Colonoscopies are performed by trained IBD specialists. Endpoints: Primary endpoint: Bowel cleansing using Boston Bowel Preparation Score (BBPS). We considered high-quality cleansing (HQC) a BBPS ≥5. Secondary endpoints: tolerability and patient satisfaction, evaluated via questionnaires filled before and after undergoing colonoscopy. Questionnaires contained items to be ranged on a scale from 1 to 10. Safety was monitored via adverse event reporting, laboratory evaluation at colonoscopy and telephonic follow-up. Statistical analysis: We used Student’s T/ANOVA and χ² tests for comparison between quantitative and qualitative variables, respectively. Software was Stata for Mac OS. We considered statistical significance a p-value &lt; 0.05. Results Seventy-seven patients have been enrolled and subsequently randomised: 31 SP+MC vs. 24 2L-PEG-a vs. 22 1L-PEG-a. Colon cleansing was similar between solutions (% of HQC: SP+MC 100% vs. 2L-PEG-a 91% vs. 1L-PEG-a 95’4%, p = 0.28). Tolerability among the different formulations was also comparable (p = 0.68). Looking at patient satisfaction, instructions for SM+MC were rated higher (p = 0.05). No serious adverse events were reported. Data can be seen in Table 1. Conclusion No differences were observed between bowel preparations in patients with IBD concerning cleansing and tolerability. Instructions for SP+MC were easier from patient’s point of view than the others. Recruiting is still active so definitive conclusions are yet to be reported.

scholarly journals Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial

2019 ◽  
Vol 12 ◽  
pp. 175628481985151 ◽  
Author(s):  
Lawrence Hookey ◽  
Gerald Bertiger ◽  
Kenneth Lee Johnson ◽  
Julia Ayala ◽  
Yodit Seifu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Bowel Preparation ◽  
Oral Solution ◽  
Right Colon ◽  
Split Dose ◽  
Colon Cleansing ◽  
Randomized Controlled ◽  
Secondary Efficacy Endpoint ◽  
Sodium Picosulfate ◽  
The Right

Background: We performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution. Methods: Eligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint assessed overall colon-cleansing quality with the Aronchick Scale (AS), and the key secondary efficacy endpoint rated quality of right colon cleansing with the Boston Bowel Preparation Scale (BBPS). Assessments were performed by a treatment-blinded endoscopist. Tolerability was assessed using the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events and laboratory evaluations. Results: The study included 901 participants: 448 for SPMC oral solution; 453 for P/MC powder. SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders versus 81.5% (369/453) responders [difference (95% confidence interval): 6.3% (1.8, 10.9)]}. The key secondary efficacy objective assessing the right colon was also met. According to the prespecified hierarchical testing, after meeting the primary and key secondary objectives, SPMC oral solution was tested for superiority to P/MC powder for the primary endpoint ( p = 0.0067). SPMC oral solution was well tolerated. Most common adverse events were nausea (3.1% versus 2.9%), headache (2.7% versus 3.1%), hypermagnesemia (2.0% versus 5.1%), and vomiting (1.3% versus 0.7%) for SPMC oral solution and P/MC powder, respectively. Conclusions: Ready-to-drink SPMC oral solution showed superior efficacy of overall colon cleansing compared with P/MC powder, with similar safety and tolerability. [ClinicalTrials.gov identifier: NCT03017235.]

scholarly journals A Randomized Prospective Study of Bowel Preparation for Colonoscopy with Low-Dose Sodium Phosphate Tablets versus Polyethylene Glycol Electrolyte Solution

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Erina Kumagai ◽  
Tomoyoshi Shibuya ◽  
Masae Makino ◽  
Takashi Murakami ◽  
Shiori Takashima ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Low Dose ◽  
Patient Acceptance ◽  
Colon Cleansing ◽  
Bowel Cleansing ◽  
Secondary Endpoints ◽  
Tablet Preparation ◽  
Sodium Phosphates ◽  
Improve Patient

Optimal bowel preparation is essential for the safety and outcome of colonoscopy. A solution containing polyethylene glycol (PEG) is often used as a bowel cleansing agent, but some patients are intolerant of PEG, and this may lead to discontinuation of colonoscopy. Sodium phosphates (NaP) tablets are designed to improve patient acceptance and compliance. The objective of this study was to compare bowel preparation efficiency and patient acceptance of a 30 NaP tablet preparation (L-NaP) and a 2 L PEG preparation. Patients were randomized into either the L-NaP or PEG group. The primary endpoint was the efficiency of colon cleansing as assessed by a validated four-point scale according to the Aronchick scale by endoscopists and was verified by blinded investigators. The secondary endpoints were patients’ tolerability and acceptance. Colon-cleansing efficiency was not significantly different between the two preparations. However, patients’ overall judgment was significantly in favor of L-NaP, reflecting better acceptance of L-NaP than PEG. Additionally, more patients favored L-NaP over PEG in a hypothetical future occasion requiring colonoscopy.

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