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 Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study

2020 ◽  
Vol 13 ◽  
pp. 175628482090287
Author(s):  
Lawrence Hookey ◽  
Gerald Bertiger ◽  
Kenneth Lee Johnson ◽  
Mena Boules ◽  
Masakazu Ando ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Age Groups ◽  
Secondary Analysis ◽  
Oral Solution ◽  
Phase Iii ◽  
Age Group ◽  
Split Dose ◽  
Sodium Picosulfate ◽  
The Right ◽  
Post Hoc

Background: The incidence and mortality of colorectal cancer (CRC) increase with age and, therefore, it is recommended that adults undergo regular CRC screening, ideally by colonoscopy, with some new guidelines recommending screening begin at 45 years. Effective bowel preparation is a critical step to a successful colonoscopy. Of concern is that older adults may have poorer quality of bowel preparation or reduced tolerability for the bowel preparation. Here, we performed a post hoc secondary analysis for the effect of age on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. Methods: A phase III, randomized, assessor-blinded, multicenter, non-inferiority study was conducted comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A post hoc secondary analysis was performed to assess efficacy, safety, and tolerability of SPMC oral solution by age group (<50 years, 50–64 years, ⩾65 years). The prespecified primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Results: Within age groups, at least 83.9% of participants were responders by the AS, and at least 91.1% of participants were responders by the BBPS in the right colon. On both scales, responder rates were highest in the youngest age group and decreased with increasing age. Greater than 88% of participants in any age group found the preparation ‘easy’ or ‘acceptable’ to ingest, with rates of ‘easy’ being highest in the oldest age group. No new safety signals were seen in any age group. The most commonly reported drug-related, treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%). Conclusion: Ready-to-drink SPMC oral solution showed good efficacy of overall colon cleansing and tolerability in adults across different age groups, including those ⩾65 years. ClinicalTrials.gov identifier: NCT03017235.

scholarly journals Efficacy and Patient Tolerability of Split-Dose Sodium Picosulfate/Magnesium Citrate (SPMC) Oral Solution Compared to the Polyethylene Glycol (PEG) Solution for Bowel Preparation in Outpatient Colonoscopy: An Evidence-Based Review

2020 ◽  
Vol Volume 13 ◽  
pp. 449-457
Author(s):  
Antonio Afonso de Miranda Neto ◽  
Diogo Turiani Hourneaux de Moura ◽  
Kelly E Hathorn ◽  
Francisco Tustumi ◽  
Eduardo Guimarães Hourneaux de Moura ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Oral Solution ◽  
Evidence Based ◽  
Magnesium Citrate ◽  
Split Dose ◽  
Sodium Picosulfate

Efficacy of the drug containing sodium picosulfate and magnesium citrate in bowel preparation for colonoscopy in children

2020 ◽  
Vol 15 (4) ◽  
pp. 32-39
Author(s):  
T.N. Budkina ◽  
◽  
V.I. Oldakovskiy ◽  
A.V. Tupylenko ◽  
V.S. Tsvetkova ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Key Words Children ◽  
Control Group ◽  
Magnesium Citrate ◽  
Right Colon ◽  
Bowel Diseases ◽  
Sodium Picosulfate ◽  
Inflammatory Bowel ◽  
The Right

Objective. To evaluate the efficacy, safety, and tolerability of the drug containing sodium picosulfate and magnesium citrate (SPMC) used for bowel preparation in children. Patients and methods. We have assessed the quality of bowel preparation for colonoscopy in 80 children aged between 9 and 18 years (40 of them received SPMC for it and another 40 were prepared by cleansing enemas). The effectiveness of bowel preparation was evaluated using the Boston and Chicago Bowel Preparation Scales (BPS). Tolerability of the SPMC preparation scheme was estimated using a specially designed questionnaire. Results. Effective bowel preparation was achieved in 85% children receiving SPMC (excellent in 27.5% of cases and good in 57.5% of cases), whereas children in the control group have demonstrated significantly lower quality of bowel preparation (p = 0.021). We have observed that the right colon was significantly better prepared in the SPMC group than in the control group (p < 0.001). Ninety percent of children were satisfied with the SPMC preparation scheme and agreed to use it in the future. Conclusion. Preparation of children for colonoscopy with SPMC was effective, safe, and well tolerated by them; therefore, SPMC is preferable over traditional cleansing enemas. Key words: children, inflammatory bowel diseases, colonoscopy, bowel preparation, sodium picosulfate–magnesium citrate

scholarly journals Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial

2021 ◽  
Vol 14 ◽  
pp. 175628482110244
Author(s):  
Gautam N. Mankaney ◽  
Masakazu Ando ◽  
David N. Dahdal ◽  
Carol A. Burke
Keyword(s):  
Citric Acid ◽  
Renal Impairment ◽  
Magnesium Oxide ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Oral Solution ◽  
Moderate Renal Impairment ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Sodium Picosulfate

Background: Selecting a bowel preparation for patients with renal impairment or diabetes requires special consideration. We aimed to describe the effect of baseline renal impairment or diabetes on the safety, efficacy, and tolerability of low-volume sodium picosulfate, magnesium oxide, and citric acid (SPMC) ready-to-drink oral solution bowel preparation. Methods: A post hoc secondary analysis was performed from a randomized, assessor-blinded study of SPMC oral solution bowel preparation in participants with mild or moderate baseline renal impairment or diabetes. Primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of ascending colon cleansing from the Boston Bowel Preparation Scale (BBPS), and selected results from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs), adenoma detection, and laboratory evaluations. Results: Similar overall colon cleansing was demonstrated in the subgroups, with >85% of participants in any subgroup rated as responders by the AS, and >92% of participant responders by the BBPS. Most participants reported a tolerable bowel preparation, regardless of baseline renal impairment or diabetes history. Safety of SPMC oral solution was similar between all subgroups and the overall cohort. For the mild renal impairment, moderate renal impairment, and diabetes subgroups, respectively, commonly reported, drug-related AEs were nausea (2.6%, 5.3%, 1.4%) and headache (2.2%, 2.6%, 4.3%). Conclusions: Ready-to-drink SPMC oral solution demonstrated efficacious colon cleansing in patients with baseline mild/moderate renal impairment or diabetes, with a tolerable bowel preparation reported by most. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03017235

scholarly journals The impact of diet liberalization on bowel preparation for colonoscopy

2017 ◽  
Vol 05 (04) ◽  
pp. E253-E260 ◽  
Author(s):  
James Walter ◽  
Gloria Francis ◽  
Rebecca Matro ◽  
Ramalinga Kedika ◽  
Rachael Grosso ◽  
...  
Keyword(s):  
Adverse Events ◽  
Bowel Preparation ◽  
Final Analysis ◽  
Study Groups ◽  
Detection Rates ◽  
Split Dose ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Low Residue Diet ◽  
The Impact

Abstract Background and study aims Dietary restrictions are integral to colonoscopy preparation and impact patient satisfaction. Utilizing split-dose, lower-volume polyethylene glycol 3350-electrolyte solution (PEG-ELS), this study compared colon preparation adequacy of a low-residue diet to clear liquids using a validated grading scale. Patients and methods This was a prospective, randomized, single-blinded, single-center non-inferiority study evaluating diet the day prior to outpatient colonoscopy. Subjects were randomized to a Low-Residue diet for breakfast and lunch, or Clears only. All subjects received split dose PEG-ELS. The primary endpoint was preparation adequacy using the Boston Bowel Preparation Scale (BBPS), with adequate defined as a score > 5. Secondary endpoints included mean BBPS scores for the entire colon and individual segments, satisfaction, adverse events, polyp and adenoma detection rates, and impact on sleep and daily activities. Results Final analysis included 140 subjects, 72 assigned to Clears and 68 to Low-Residue. The Low-Residue diet was non-inferior to Clears (risk difference = – 5.08 %, P = 0.04) after adjusting for age. Mean colon cleansing scores were not significantly different overall and for individual colonic segments. Satisfaction with the Low-Residue diet was significantly greater (P = 0.01). The adenoma detection rate was not statistically significantly different between study groups, but the number of adenomas detected was significantly greater with Clears (P = 0.01). Adverse events and impact on sleep and activities did not differ significantly between diet arms. Conclusions A low-residue diet for breakfast and lunch the day prior to colonoscopy was non-inferior to clear liquids alone for achieving adequate colon cleansing when using split dose PEG-ELS.

scholarly journals Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study

2020 ◽  
Vol 13 ◽  
pp. 175628482091005
Author(s):  
Lawrence Hookey ◽  
Gerald Bertiger ◽  
Kenneth Lee Johnson ◽  
Mena Boules ◽  
Masakazu Ando ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Body Mass ◽  
Bowel Preparation ◽  
Safety Data ◽  
Secondary Analysis ◽  
Oral Solution ◽  
Phase Iii ◽  
Right Colon ◽  
The Right ◽  
Post Hoc

Background: We performed a post hoc secondary analysis for the effect of body mass index (BMI) on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. Methods: A phase III, randomized, assessor-blinded, multicenter, noninferiority study was conducted comparing split-dose, low-volume SPMC oral solution with a powder formulation for oral solution. A post hoc secondary analysis assessed efficacy, safety, and tolerability of SPMC oral solution stratified by BMI. BMI was classified by Centers for Disease Control and Prevention definitions (underweight and normal weight: BMI < 25 kg/m2; overweight: BMI 25–29.9 kg/m2; class I obesity: BMI 30–34.9 kg/m2; class II obesity: BMI 35–39.9 kg/m2; class III/severe obesity: BMI ⩾40 kg/m2). Prespecified primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Results: Between 82.8% and 92.5% of participants in any BMI group were responders by AS, and between 91.3% and 100% were responders by BBPS in the right colon. Efficacy was consistent across BMI groups, with no clear trends. Greater than 83% of participants in any BMI group found the preparation ‘easy’ or ‘acceptable’ to ingest, and the majority (>58%) rated SPMC oral solution as ‘better’ than a prior bowel preparation. In all BMI groups, safety data were similar to the overall cohort. Commonly reported, drug-related, treatment-emergent AEs were, by ascending BMI group, nausea (1.1%, 5.3%, 1.0%, 5.7%, and 0%) and headache (1.1%, 4.1%, 1.0%, 5.7%, and 0%). Conclusions: Ready-to-drink SPMC oral solution had consistent, good quality colon cleansing, and favorable tolerability among participants of all BMI groups. ClinicalTrials.gov Registration: NCT03017235

Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial

Endoscopy ◽  
2018 ◽  
Vol 51 (01) ◽  
pp. 73-84 ◽  
Author(s):  
Stefan Schreiber ◽  
Daniel Baumgart ◽  
Joost Drenth ◽  
Rafał Filip ◽  
Lucy Clayton ◽  
...  
Keyword(s):  
Magnesium Citrate ◽  
Right Colon ◽  
High Quality ◽  
Phase 3 ◽  
Colon Cleansing ◽  
Intention To Treat ◽  
Full Analysis ◽  
Sodium Picosulfate ◽  
Bowel Preparations ◽  
The Right

Abstract 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 %; P = 0.04) and high-quality cleansing in the right colon (4.4 % vs. 1.2 %; P = 0.03). Superiority of NER1006 was demonstrated using HCS in the PP set for overall cleansing success (68.0 % vs. 57.5 %; P = 0.02) and right colon high-quality cleansing (5.2 % vs. 1.0 %; P = 0.02) and using BBPS in the mFAS for overall cleansing success (58.4 % vs. 45.8 %; P = 0.003) and right colon high-quality cleansing (4.0 % vs. 0.8 %; P = 0.02). Mean segmental scores for 4/5 segments were higher with NER1006 (P ≤ 0.04). Both treatments were well tolerated, with more mild adverse events for NER1006 (17.0 % vs. 10.0 %; P = 0.03). 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/

scholarly journals Impact of second forward-view examination on adenoma detection rate during unsedated colonoscopy: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keshu Shan ◽  
Hongpeng Lu ◽  
Zhixin Zhang ◽  
Jiarong Xie ◽  
Lu Xu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Detection Rate ◽  
Controlled Trial ◽  
Lesion Detection ◽  
Adenoma Detection Rate ◽  
Right Colon ◽  
Randomized Controlled ◽  
Adenoma Detection ◽  
Advanced Lesion ◽  
The Right

Abstract Objectives Colorectal cancer on the right side of the colon has been suggested to be harder to detect by colonoscopy. The aim of this study was to evaluate whether a second forward-view examination of the right side of the colon could increase the adenoma detection rate (ADR) and/or polyp detection rate (PDR). Methods This was a single-centre randomized controlled trial. Patients undergoing colonoscopy were recruited and randomly assigned to the second forward-view examination (SFE) group, in which the right side of the colon was examined twice or the traditional colonoscopy (TC) group in which the colonoscopy was performed in a standard manner. The primary outcome was the ADR of right colon. The overall PDR and ADR, PDR of the right colon, per-adenoma miss rate of the right colon, and advanced lesion detection rate were also recorded and compared. Results A total of 392 patients were included in the study (SFE group 197 vs. TC group 195). The ADR and PDR of the right colon in the SFE group were significantly higher than those in the TC group (ADR 10.7% vs. 5.1%; P = 0.042); PDR 17.8% vs. 9.7%, P = 0.021). No significant difference was found in overall PDR/ADR, or advanced lesion detection rate between the two groups. Conclusions This prospective controlled study revealed that a second forward-view examination could modestly increase the ADR and PDR of the right colon during unsedated colonoscopies. This simple, safe and time-effective technique might be recommended for routine unsedated colonoscopy. Trial registration: Clinical Trials.gov, NCT03619122. Registered on 7/8/2018.

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