Page last updated: 2024-11-04

picosulfate sodium

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

picosulfate sodium: contains two active ingredients, sodium picosulfate and magnesium citrate, which are both laxatives; structure [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID68654
CHEMBL ID1697768
CHEBI ID32147
SCHEMBL ID346436
MeSH IDM0047418

Synonyms (79)

Synonym
evanol
pico-salax
sodium picosulphate
laxoberon
picolax
picosulfol
laxidogol
laxoberal
sodium picosulfate [inn:ban:jan]
guttalax
4,4'-(2-pyridylmethylene)diphenol bis(hydrogen sulfate) disodium salt
2-picolylidenebis(p-phenyl sodium sulfate)
einecs 233-120-9
natrii picosulfas [inn-latin]
4,4'-(2-picolylidene)bis(phenylsulfuric acid) disodium salt
neopax
4,4'-(2-pyridylmethylene)diphenolbis(hydrogen sulfate) (ester) disodium salt
picosulfate de sodium [inn-french]
disodium 4,4'-disulfoxydiphenyl-(2-pyridyl)methane
phenol, 4,4'-(2-pyridylmethylene)bis-, bis(hydrogen sulfate), disodium salt
4,4'-(2-pyridinylmethylene)bisphenol bis(hydrogen sulfate) (ester) disodium salt
picosulfate sodium
picosulfato sodico [inn-spanish]
da-1773
rapilax
10040-45-6
sodium picosulfate
4,4'-(2-pyridinylmethylene)bisphenol 1,1'-bis(hydrogen sulfate) sodium salt
guttalax-fher
la-391
sodium picosulfate anhydrous
sodium picosulphate anhydrous
picosulfate sodium anhydrous
da 1773
picosulfate sodium hydrate
sodium picosulphate monohydrate
chebi:32147 ,
CHEMBL1697768
la 391
NCGC00182711-01
picosulfate de sodium
picoprep
vw106606y8 ,
unii-vw106606y8
natrii picosulfas
picosulfato sodico
evacuol
tox21_113026
cas-10040-45-6
dtxsid7048663 ,
dtxcid0028589
S4020
FT-0673898
SCHEMBL346436
GOZDTZWAMGHLDY-UHFFFAOYSA-L
picosulfate sodium [mi]
4,4'-(2-pyridylmethylene)diphenol bis(hydrogen sulphate) disodium salt
sodium picosulfate [inn]
AC-31735
S0936
sodium (pyridin-2-ylmethylene)bis(4,1-phenylene) bis(sulfate)
HMS3652K17
natriumpicosulfat
disodium;[4-[pyridin-2-yl-(4-sulfonatooxyphenyl)methyl]phenyl] sulfate
SW219183-1
AKOS030632777
disodium 4,4'-(2-pyridylmethylene)-di(phenyl sulphate);disodium 4,4'-(2-pyridylmethylene)-di(phenyl sulphate);sodium picosulfate
anhydrous sodium picosulfate
Q410265
4-methyl-2-pentenoicacid
mfcd00867640
AS-15785
BCP11522
CCG-269559
sodium picosulfate 100 microg/ml in acetonitrile
C71029
picosulfate for system suitability
sodium 4,4'-(pyridin-2-ylmethylene)bis(4,1-phenylene) disulfate
guttalax;laxoberon

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"There are few studies supporting the effective and safe use of laxatives for constipation."( Randomised, placebo-controlled, double-blind study to investigate the efficacy and safety of the acute use of sodium picosulphate in patients with chronic constipation.
Jordan, C; Kamm, MA; Peil, H; Schuijt, C; Vix, JM; Wulkow, R, 2007
)
0.34
" This observational study with 737 patients evaluated efficacy of bowel preparation, potential side or adverse effects and patient acceptance of this medicinal product when used by resident physicians in Germany."( Observational multicentric study to evaluate efficacy, adverse effects and acceptance of bowel cleansing prior to colonoscopy with sodium picosulfate / magnesium citrate formulation CitraFleet®.
Deissler, H; Janisch, HD; Koppold, B; Riemann, JF, 2016
)
0.43
" No medication-related adverse events were reported."( Efficacy and Safety of Sodium Picosulfate/Magnesium Citrate for Bowel Preparation in a Physically Disabled Outpatient Population: A Randomized, Endoscopist-Blinded Comparison With Ascorbic Acid-Enriched Polyethylene Glycol Solution Plus Bisacodyl (The PIC
Mathus-Vliegen, EMH; Stadwijk, JS; van der Vliet, K; Wignand-van der Storm, IJ, 2018
)
0.48
" The grade of bowel preparation and any related side effect were evaluated."( Bowel Preparation for Gastrointestinal Endoscopic Procedures With Sodium Picosulphate-Magnesium Citrate Is an Effective, Safe, and Well-Tolerated Option in Pediatric Patients: A Single-Center Experience.
Andrealli, A; Barletti, C; Calvo, P; Cisarò, F; Guanà, R; Pinon, M,
)
0.13
"Magnesium citrate with sodium picosulfate is outstandingly effective, well tolerated and a safe agent in colonoscopy preparation."( Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate - a phase IV clinical observational study.
Bálint, A; Bor, R; Fabián, A; Farkas, K; Matuz, M; Milassin, Á; Molnár, T; Pigniczki, D; Rutka, M; Szántó, K; Szepes, Z; Tóth, T, 2021
)
0.62
" Diarrhea, nausea, bloating, and abdominal pain were common adverse events, but no serious adverse events were reported."( Efficacy and Safety of Over-the-Counter Therapies for Chronic Constipation: An Updated Systematic Review.
Brenner, DM; Rao, SSC, 2021
)
0.62

Bioavailability

ExcerptReferenceRelevance
" We have investigated the alterations of the bioavailability of glycyrrhizin when SGT was co-administered with sodium picosulfate and we tried to identify a regimen that might minimize the alterations."( Bioavailability of glycyrrhizin from Shaoyao-Gancao-Tang in laxative-treated rats.
Akao, T; Goto, E; He, JX; Tani, T, 2005
)
0.33
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" The median daily dose to achieve this was 15 mg (range: 5-30 mg) and the median time to first bowel movement after dosing was 11."( Sodium picosulfate in opioid-induced constipation: results of an open-label, prospective, dose-ranging study.
Jordan, C; Kamm, MA; McNamara, P; Schuijt, C; Twycross, RG, 2006
)
0.33
" Compliance with the recommended dosage of 5 â 10 mg/day was 96%, compliance with the indication of constipation was 99%."( OTC laxative use of sodium picosulfate â results of a pharmacy-based patient survey (cohort study).
Erckenbrecht, JF; Hinkel, U; Schuijt, C, 2008
)
0.35
" C(max) was attained approximately 5 h after dosing of Bisa and 9 h after dosing of SPS."( Absence of excretion of the active moiety of bisacodyl and sodium picosulfate into human breast milk: an open-label, parallel-group, multiple-dose study in healthy lactating women.
de Kruif, S; Friedrich, C; Gessner, U; Mandel, K; Richter, E; Trommeshauser, D; van Iersel, T, 2011
)
0.37
"The split-dose regimen of picosulfate, magnesium oxide, and citric acid solution is superior to the traditional dosing regimen for colon cleansing before colonoscopy."( Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial.
Flemming, JA; Hookey, LC; Vanner, SJ, 2012
)
0.38
" Nonetheless, this could have implications in patients with pre-existing electrolyte abnormalities and the safety of dosing with more than two sachets."( Serial monitoring of the physiological effects of the standard Pico-Salax® regimen for colon cleansing in healthy volunteers.
Baranchuk, A; Hookey, LC; Rahman, A; Vanner, SJ, 2012
)
0.38
"Split dosage of bowel preparations has been shown to substantially improve bowel cleansing."( [Split-dose sodium picosulphate/magnesium citrate for morning colonoscopies performed 2 to 6 hours after fluid intake].
Dueñas-Sadornil, C; Fernández-Bermejo, M; González-Santiago, JM; Hernández-Alonso, M; Martín-Noguerol, E; Martínez-Alcalá, C; Mateos-Rodríguez, JM; Molina-Infante, J; Pérez-Gallardo, B; Vinagre-Rodríguez, G, 2013
)
0.39
"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)."( Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study.
Alderfer, V; Bertiger, G; Hookey, LC; Joseph, RE; Katz, PO; Rex, DK; Vanner, S, 2013
)
0.39
"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."( Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study.
Alderfer, V; Bertiger, G; Hookey, LC; Joseph, RE; Katz, PO; Rex, DK; Vanner, S, 2013
)
0.39
" This study evaluates whether split dosing is associated with a further increase in efficacy and acceptability compared with the standard dosing regimen."( Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy.
Hassan, C; Manes, G; Repici, A, 2014
)
0.4
" Adult outpatients undergoing colonoscopy received PMC either in the standard dosing (two sachets taken the day before endoscopy) or in split dosing (the second sachet taken on the morning of colonoscopy)."( Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy.
Hassan, C; Manes, G; Repici, A, 2014
)
0.4
" This means that having developed a printable formulation, printed pharmaceutical dosage forms can be obtained on any pharmaceutical grade substrate, such as polymer-based films."( Pharmaceutical-grade oral films as substrates for printed medicine.
Hsiao, WK; Markl, D; Paudel, A; Pichler, H; Planchette, C; Stegemann, S; Wimmer-Teubenbacher, M, 2018
)
0.48
" Recently many studies have attempted to find the most ideal regimens, and more convenient, effective, and safe regimens have been developed by reducing the dosing volume and improving the taste."( [Optimal Laxatives for Oral Colonoscopy Bowel Preparation: from High-volume to Novel Low-volume Solutions].
Moon, W; Na, SY, 2020
)
0.56
" Pediatric inpatients undergoing colonoscopy received SPMC either in the day-before dosing or in split dosing."( Split-dose versus day-before regimen of sodium picosulfate plus magnesium citrate for bowel cleansing before colonoscopy in children: Randomized controlled trial.
Di Nardo, G; Evangelisti, M; Felici, E; Furio, S; Hassan, C; Lucchini, L; Massolo, AC; Mennini, M; Parisi, P; Piccirillo, M; Quatrale, G; Strisciuglio, C; Zenzeri, L, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
aryl sulfate
pyridinesAny organonitrogen heterocyclic compound based on a pyridine skeleton and its substituted derivatives.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (1)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
estrogen nuclear receptor alphaHomo sapiens (human)Potency11.98560.000229.305416,493.5996AID743069
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (7)

Assay IDTitleYearJournalArticle
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (221)

TimeframeStudies, This Drug (%)All Drugs %
pre-199025 (11.31)18.7374
1990's39 (17.65)18.2507
2000's38 (17.19)29.6817
2010's99 (44.80)24.3611
2020's20 (9.05)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials98 (42.24%)5.53%
Reviews15 (6.47%)6.00%
Case Studies15 (6.47%)4.05%
Observational5 (2.16%)0.25%
Other99 (42.67%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (48)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy. [NCT01065857]Phase 3547 participants (Anticipated)Interventional2010-01-31Completed
Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure [NCT05726097]Phase 3147 participants (Anticipated)Interventional2023-02-01Recruiting
Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing [NCT01292109]252 participants (Actual)Observational2010-12-31Completed
Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy [NCT03698474]Phase 4612 participants (Actual)Interventional2018-10-25Completed
Drug Use-Results Survey on Picoprep® Combination Powder [NCT03631446]1,298 participants (Actual)Observational2017-08-29Completed
The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial [NCT02410720]160 participants (Actual)Interventional2013-06-30Completed
Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study [NCT01093274]200 participants (Anticipated)InterventionalNot yet recruiting
PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial. [NCT01649674]Phase 4525 participants (Anticipated)Interventional2011-11-30Active, not recruiting
A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Pow [NCT03017235]Phase 3917 participants (Actual)Interventional2017-02-20Completed
Pre-Operative Mechanical Bowel Preparation And Prophylactic Oral Antibiotics For Pediatric Patients Undergoing Elective Colorectal Surgery: A Feasibility Randomized Controlled Trial [NCT03593252]81 participants (Anticipated)Interventional2022-01-01Not yet recruiting
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops 10 mg Administered Orally, Once Daily, in Patients With Functional Constipatio [NCT00576810]Phase 3367 participants (Actual)Interventional2007-10-31Completed
The Efficacy of Chewing Gums Versus Laxatives in Early Return of Bowel Function After Cesarean Section [NCT02765971]Phase 4540 participants (Anticipated)Interventional2016-05-31Recruiting
A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy [NCT02956057]Phase 41,044 participants (Actual)Interventional2016-11-12Completed
A Prospective Audit of Tolerability, Mucosal Cleansing Efficacy and Mucosal Abnormalities Associated With Standard Orally Administered Colon Cleansing Preparations for Colonoscopy [NCT00750763]Phase 4676 participants (Actual)Interventional2008-01-31Completed
A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatien [NCT02386449]Phase 4184 participants (Actual)Interventional2015-02-28Completed
A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy [NCT01356407]Phase 3300 participants (Actual)Interventional2011-01-31Completed
Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial [NCT04033250]600 participants (Anticipated)Interventional2019-09-30Recruiting
Investigations of the Endocrine Colon in Healthy Individuals [NCT04159181]10 participants (Anticipated)Interventional2018-07-16Active, not recruiting
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing [NCT04598880]Phase 41,104 participants (Anticipated)Interventional2020-11-06Recruiting
Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy [NCT04153084]126 participants (Anticipated)Observational2018-10-01Recruiting
Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial) [NCT01919255]Phase 2236 participants (Actual)Interventional2013-08-31Completed
A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study [NCT01909219]Phase 4862 participants (Actual)Interventional2012-01-31Completed
A Prospective, Randomized Controlled Clinical Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy [NCT01984008]Phase 3631 participants (Actual)Interventional2013-10-23Completed
Preparation Prior to Colonoscopy in Children [NCT02009202]71 participants (Actual)Interventional2012-11-30Completed
A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Pre [NCT02024022]Phase 4185 participants (Actual)Interventional2014-02-28Completed
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery : Phase II. Prospective, Randomised, Multicenter, Non-inferiority Trial [NCT04593446]Phase 2414 participants (Anticipated)Interventional2020-11-01Recruiting
Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females [NCT02211911]Phase 116 participants (Actual)Interventional2008-02-29Completed
Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy [NCT01685970]Phase 3200 participants (Anticipated)Interventional2012-09-30Recruiting
"A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of Day Before PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy" [NCT01073943]Phase 3603 participants (Actual)Interventional2010-05-31Completed
"A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of Split-Dose PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy" [NCT01073930]Phase 3608 participants (Actual)Interventional2010-05-31Completed
Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC) [NCT04474002]Phase 4158 participants (Anticipated)Interventional2020-12-07Recruiting
Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation: Propensity Score Analysis for Interventional Effectiveness Evaluation [NCT03074448]Phase 3314 participants (Actual)Interventional2014-05-31Completed
Phase IV, Prospective, Randomized Study Comparing Preparation the Day Before and Split-dose Regimen With Sodium Picosulphate/Magnesium Citrate for Morning Colonoscopies [NCT01481714]Phase 4300 participants (Anticipated)Interventional2011-11-30Recruiting
A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®) [NCT00312481]Phase 265 participants (Actual)Interventional2005-07-31Completed
Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study [NCT00460837]Phase 4150 participants (Anticipated)Interventional2007-11-30Withdrawn(stopped due to Supply of adequate label was not provided to the MHRA)
Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial. [NCT05144295]Phase 3274 participants (Actual)Interventional2022-01-01Completed
A Randomized Controlled Study Comparing PicoSalax, Versus PicoSalax and Fleet Enema Versus Fleet Enema Alone for Sigmoidoscopy [NCT01554111]Phase 4120 participants (Actual)Interventional2012-03-31Completed
A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy. [NCT01603654]Phase 4300 participants (Actual)Interventional2011-01-31Completed
A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients [NCT01627171]Phase 4126 participants (Anticipated)Interventional2012-09-30Recruiting
EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN [NCT01711437]Phase 4400 participants (Anticipated)Interventional2011-01-31Recruiting
A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy [NCT01778192]Phase 3200 participants (Actual)Interventional2012-07-31Completed
Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial [NCT03581149]Phase 468 participants (Anticipated)Interventional2018-03-26Recruiting
Oral + Parenteral Antibiotic Prophylaxis Before Colonic Surgery With vs Without Mechanical Bowel Preparation: a Prospective, Multicentric, Randomised, Controlled Trial. [NCT04161599]Phase 4968 participants (Anticipated)Interventional2022-03-01Recruiting
[NCT01596686]184 participants (Actual)Interventional2012-05-31Completed
Randomized Comparison of the Impact of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Versus Polyethylene Glycol Bowel Preparation on Inpatient Colonoscopy Quality Parameters [NCT03198221]Phase 414 participants (Actual)Interventional2018-07-11Terminated(stopped due to Low enrollment due to difficult eligibility criteria and participant prep logistics)
Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial) [NCT02979223]Phase 2142 participants (Actual)Interventional2016-11-30Completed
A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy [NCT05436054]Phase 4400 participants (Anticipated)Interventional2022-10-01Recruiting
A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy [NCT02239692]Phase 3204 participants (Actual)Interventional2014-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01073930 (9) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?
NCT01073930 (9) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?
NCT01073930 (9) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
NCT01073930 (9) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
NCT01073930 (9) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
NCT01073930 (9) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
NCT01073930 (9) [back to overview]Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
NCT01073930 (9) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01073930 (9) [back to overview]Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
NCT01073943 (10) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?
NCT01073943 (10) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?
NCT01073943 (10) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
NCT01073943 (10) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
NCT01073943 (10) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
NCT01073943 (10) [back to overview]Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
NCT01073943 (10) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01073943 (10) [back to overview]Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
NCT01073943 (10) [back to overview]Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
NCT01073943 (10) [back to overview]Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
NCT01356407 (6) [back to overview]The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
NCT01356407 (6) [back to overview]Ottawa Scale Score by Colon Segment
NCT01356407 (6) [back to overview]Patient Response to Acceptability and Tolerability Questionnaire
NCT01356407 (6) [back to overview]Percentage of Successful Completion of Colonoscopy
NCT01356407 (6) [back to overview]Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
NCT01356407 (6) [back to overview]Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
NCT02239692 (6) [back to overview]Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
NCT02239692 (6) [back to overview]Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
NCT02239692 (6) [back to overview]Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
NCT02239692 (6) [back to overview]Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
NCT02239692 (6) [back to overview]Frequency and Intensity of Adverse Events
NCT02239692 (6) [back to overview]Ascending Colon Cleansing Responder Status (ITT)
NCT02956057 (2) [back to overview]Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
NCT02956057 (2) [back to overview]Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
NCT03017235 (23) [back to overview]"Percentage of Subjects Classified as a Responder Defined by Excellent or Good"
NCT03017235 (23) [back to overview]Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
NCT03017235 (23) [back to overview]Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
NCT03017235 (23) [back to overview]Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
NCT03017235 (23) [back to overview]Clinically Significant Changes in Laboratory Values
NCT03017235 (23) [back to overview]Clinically Significant Changes in Electrocardiogram (ECG)
NCT03017235 (23) [back to overview]Percentage of Treatment-emergent Adverse Events(AEs)
NCT03017235 (23) [back to overview]Clinically Significant Changes in Vital Signs
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
NCT03017235 (23) [back to overview]Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
NCT03198221 (2) [back to overview]Proportion of Participants Requiring a Repeat Colonoscopy
NCT03198221 (2) [back to overview]Percentage of Participants With Satisfactory Bowel Cleansing

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
YesNo
HalfLytely13.586.5
PICOPREP1.798.3

[back to top]

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
YesNo
HalfLytely54.745.3
PICOPREP96.04.0

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
YesNo
HalfLytely89.910.1
PICOPREP99.01.0

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
ExcellentGoodTolerablePoorBad
HalfLytely2.718.956.213.19.1
PICOPREP23.450.525.70.30

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
ExcellentGoodFairPoorBad
HalfLytely16.642.928.77.14.7
PICOPREP46.845.26.61.00.3

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
Very easyEasyTolerableDifficultVery difficult
HalfLytely8.120.947.014.99.1
PICOPREP57.931.59.61.00

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Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist

Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary. (NCT01073930)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
Ascending colonMid colonRecto-sigmoid colonOverall: ascending, mid, and recto-sigmoid colon
HalfLytely78.885.987.275.4
PICOPREP89.592.492.486.8

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Participants With Treatment-Emergent Adverse Events (TEAEs)

Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication. (NCT01073930)
Timeframe: up to one month

,
Interventionparticipants (Number)
Any TEAEDeathSerious AETEAEs leading to discontinuation of study drugSevere TEAEsRelated TEAEs
HalfLytely217021626
PICOPREP211010219

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Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist

Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. (NCT01073930)
Timeframe: Day 2

Interventionpercentage of participants (Number)
PICOPREP84.2
HalfLytely74.4

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
YesNo
HalfLytely14.485.6
PicoPrep4.895.2

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
YesNo
HalfLytely59.440.6
PicoPrep93.26.8

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
YesNo
HalfLytely92.37.7
PicoPrep99.70.3

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
ExcellentGoodTolerablePoorBad
HalfLytely4.023.852.312.17.7
PicoPrep25.648.123.91.70.7

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
Very easyEasyTolerableDifficultVery difficult
HalfLytely16.121.145.311.75.7
PicoPrep58.429.011.61.00

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Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist

Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here. (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
Mid-colonRecto-sigmoid colonOverall: ascending, mid, and recto-sigmoid colon
HalfLytely88.789.078.0
PicoPrep93.292.278.9

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Participants With Treatment-Emergent Adverse Events (TEAEs)

Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication. (NCT01073943)
Timeframe: up to one month

,
Interventionparticipants (Number)
Any TEAEDeathsSerious AETEAEs leading to discontinuation of study drugSevere TEAEsRelated TEAEs
HalfLytely241011629
PicoPrep218020533

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Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist

Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary. (NCT01073943)
Timeframe: Day 2

Interventionpercentage of participants (Number)
PicoPrep81.3
HalfLytely84.0

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Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad (NCT01073943)
Timeframe: Day 2

,
Interventionpercentage of participants (Number)
ExcellentGoodFairPoorBad
HalfLytely19.148.725.53.43.4
PicoPrep45.543.89.20.70.7

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Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist

Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. (NCT01073943)
Timeframe: Day 2

Interventionpercentage of participants (Number)
PicoPrep83.0
HalfLytely79.7

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The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation

The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel) (NCT01356407)
Timeframe: day 2

Interventionunits on a scale (Mean)
PICOPREP4.73
Hengkang Zhengqing (PEG-ELS)4.91

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Ottawa Scale Score by Colon Segment

Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score (NCT01356407)
Timeframe: Day 2

,
Interventionunits on a scale (Mean)
AscendingTransverse/descendingRectosigmoidOverall fluid content (score)
Hengkang Zhengqing (PEG-ELS)1.731.331.230.62
PICOPREP1.561.431.250.49

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Patient Response to Acceptability and Tolerability Questionnaire

On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)). (NCT01356407)
Timeframe: Day 2

,
Interventionunits on a scale (Mean)
Abdominal BloatingSpasmsNauseaVomitingGeneral MalaiseEase of Taking Study MedicationDegree of Acceptability to Study MedPalatability of Study Medication
Hengkang Zhengqing (PEG-ELS)1.451.121.641.251.602.082.152.62
PICOPREP1.311.131.221.031.311.521.461.64

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Percentage of Successful Completion of Colonoscopy

An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve) (NCT01356407)
Timeframe: Day 2

,
InterventionPercentage of Subjects (%) (Number)
NoYes
Hengkang Zhengqing (PEG-ELS)0100
PICOPREP0100

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Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation

The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation (NCT01356407)
Timeframe: Day 2

,
Interventionparticipants (Number)
NoYes
Hengkang Zhengqing (PEG-ELS)1379
PICOPREP1395

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Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)

"At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality adequate for clinical diagnostic purposes (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes" (NCT01356407)
Timeframe: Day 2

,
Interventionunits on a scale (Mean)
Adequate bowel preparationInadequate bowel preparation
Hengkang Zhengqing (PEG-ELS)4.639.22
PICOPREP4.5410.00

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Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale

Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). (NCT02239692)
Timeframe: Day 1 (day of colonoscopy)

Interventionscore on a scale (Mean)
PICOPREP Day-before Dosing Schedule8.2
PICOPREP Tailored Dosing Schedule4.2

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Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale

Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). (NCT02239692)
Timeframe: Day 1 (day of colonoscopy)

Interventionscore on a scale (Mean)
PICOPREP Day-before Dosing Schedule8.1
PICOPREP Tailored Dosing Schedule3.7

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Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)

Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory. (NCT02239692)
Timeframe: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

,
Interventionsubjects (Number)
Clinically significant change in haematologyClinically significant change in clinical chemClinically significant change in coagulationClinically significant change in urinalysis
PICOPREP Day-before Dosing Schedule0000
PICOPREP Tailored Dosing Schedule0000

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Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)

Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic). (NCT02239692)
Timeframe: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

,
Interventionsubjects (Number)
Clinically significant change in pulseClinically significant change in blood pressure
PICOPREP Day-before Dosing Schedule00
PICOPREP Tailored Dosing Schedule00

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Frequency and Intensity of Adverse Events

(NCT02239692)
Timeframe: From baseline (screening) up to day 10 after colonoscopy

,
Interventionsubjects (Number)
Frequency of all adverse eventsFrequency of mild adverse eventsFrequency of moderate adverse eventsFrequency of severe adverse events
PICOPREP Day-before Dosing Schedule4400
PICOPREP Tailored Dosing Schedule151221

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Ascending Colon Cleansing Responder Status (ITT)

Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules. (NCT02239692)
Timeframe: Day 1 (day of colonoscopy)

Interventionpercentage of subjects (Number)
PICOPREP Day-before Dosing Schedule15.1
PICOPREP Tailored Dosing Schedule61.1

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Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)

Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) (NCT02956057)
Timeframe: One day

InterventionParticipants (Count of Participants)
PEG1D56
PEG2D72
SPMC1D134
SPMC2D139
PEGA1D85
PEGA2D80

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Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)

Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) (NCT02956057)
Timeframe: One day

InterventionParticipants (Count of Participants)
PEG1D110
PEG2D145
SPMC1D100
SPMC2D134
PEGA1D121
PEGA2D55

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"Percentage of Subjects Classified as a Responder Defined by Excellent or Good"

"The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale." (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

InterventionPercentage of participants (Number)
NaP/MC Oral Solution87.7
PREPOPIK®81.5

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Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon

"The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.~The BBPS scale:~0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid." (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

InterventionPercentage of subjects (Number)
NaP/MC Oral Solution94.6
PREPOPIK®91.2

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Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon

"The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.~The BBPS scale:~0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid." (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

InterventionPercentage of subjects (Number)
NaP/MC Oral Solution94.2
PREPOPIK®89.6

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Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon

"The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.~The BBPS scale:~0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid." (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

InterventionPercentage of subjects (Number)
NaP/MC Oral Solution96.0
PREPOPIK®94.0

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Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
YesNoNo difficultiesNo health issuesResponse not provided
NaP/MC Oral Solution11104310840
PREPOPIK®8933201093

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Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
NoYesResponse not providedNot applicable
NaP/MC Oral Solution26118511
PREPOPIK®28117120

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not willing at allSomewhat willingMostly willingNot applicable
NaP/MC Oral Solution11753611
PREPOPIK®6384081

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
<25%25% - 50%50% - 75%≥75%Response not providedNot applicable
NaP/MC Oral Solution44310121
PREPOPIK®44812011

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
≤3/week4 to 8/week≥9/weekResponse not providedNot applicable
NaP/MC Oral Solution6326412001
PREPOPIK®4729910511

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution41623621
PREPOPIK®43511240

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution335862511
PREPOPIK®328853730

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution396381301
PREPOPIK®39647721

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution382531021
PREPOPIK®38757630

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution40335721
PREPOPIK®40240641

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution371631112
PREPOPIK®42622230

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Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Not bothered-Mildly botheredModerately botheredSeverely botheredNo responseNot applicable
NaP/MC Oral Solution42715312
PREPOPIK®43215321

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Clinically Significant Changes in Laboratory Values

Rated by the investigator based on out of range laboratory values (NCT03017235)
Timeframe: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy

,
InterventionParticipants (Count of Participants)
Hematology: AnaemiaHematology: LeukopeniaHematology: LymphocytosisHematology: NeutropeniaHematology: Normocytic anaemiaHemotology: Platelet count decreasedClinical Chemistry: HypermagnesaemiaClinical chemistry:Blood bicarbonate decreasedClinical chemistry: HypokalemiaClinical chemistry: HyperglycaemiaClinical chemistry: HypoglycaemiaClinical chemistry: HyperkalaemiaClinical chemistry: HypomagnasaemiaClinical chemistry: Blood creatinine increasedClinical chemistry: Blood potassium decreasedClinical chemistry: HypochloraemiaClinical chemistry: HyperbilirubinaemiaUrinalysis
NaP/MC Oral Solution110110964230201000
PREPOPIK®1010012330102010110

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Clinically Significant Changes in Electrocardiogram (ECG)

Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing. (NCT03017235)
Timeframe: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy

,
InterventionParticipants (Count of Participants)
BradycardiaBundle branch block leftExtrasystolesVentricular extrasystolesAtrial fibrillationBundle branch block rightPalpitationsSinus bradycardiaTachycardiaCardiac murmur
NaP/MC Oral Solution3002111001
PREPOPIK®0220000110

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Percentage of Treatment-emergent Adverse Events(AEs)

Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs. (NCT03017235)
Timeframe: From baseline (screening) up to day 28 after colonoscopy

InterventionPercentage of adverse events (Number)
NaP/MC Oral Solution84.4
PREPOPIK®84.8

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Clinically Significant Changes in Vital Signs

Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position (NCT03017235)
Timeframe: From baseline (screening) up to day 28 after colonoscopy

,
InterventionParticipants (Count of Participants)
HypertensionOrthostatic hypotensionBlood pressure increasedHypotension
NaP/MC Oral Solution0121
PREPOPIK®4201

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Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
Easy to acceptableSomewhat difficultVery difficultUnacceptableNot applicable
NaP/MC Oral Solution40041421
PREPOPIK®43317111

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Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)

Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. (NCT03017235)
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)

,
InterventionParticipants (Count of Participants)
GoLytelyMoviprepMiraLaxOtherDo not remember
NaP/MC Oral Solution56142034137
PREPOPIK®5217203953

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Proportion of Participants Requiring a Repeat Colonoscopy

Participants requiring a repeat procedure due to unsatisfactory bowel prep (NCT03198221)
Timeframe: 1 day

InterventionParticipants (Count of Participants)
Group A0
Group B0
Group C0
Group D0

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Percentage of Participants With Satisfactory Bowel Cleansing

Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire mucosa is seen well with no residual staining, small fragments of stool or opaque liquid). A total BBPS score of 6 or greater AND 2 or greater in all segments will be defined as satisfactory bowel prep. BBPS score of less than 6 or less than 2 in any segment of the colon will be taken as unsatisfactory bowel cleansing in the final analysis. (NCT03198221)
Timeframe: 1 day

InterventionParticipants (Count of Participants)
Group A2
Group B2
Group C4
Group D2

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