Study Summary
This trial is testing whether a low-volume bowel preparation is as effective as a standard high-volume preparation for hospitalized patients undergoing colonoscopy.
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: At time of procedure, approximately 45 minutes
Day 5
Hospital Length of Stay
At time of procedure, approximately 45 minutes
BBPS Score During Colonoscopy Withdrawal For Each Segment
Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal
Cecal Intubation Rate
Cecal Intubation Time
Colonoscopy Withdrawal Time
Intestines
Time to Endoscopy
Immediately prior to procedure
Intestines
Day 3
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
MiraLAX 306 g (Day-Prior)
60%Bloating
33%Nausea
33%Abdominal Cramps/Pain
9%Vomiting
Trial Design
2 Treatment Groups
GoLYTELY
1 of 2
MoviPrep
1 of 2
Active Control
Experimental Treatment
450 Total Participants · 2 Treatment Groups
Primary Treatment: MoviPrep · No Placebo Group · Phase 4
MoviPrep
Drug
Experimental Group · 1 Intervention: MoviPrep · Intervention Types: DrugGoLYTELY
Drug
ActiveComparator Group · 1 Intervention: Golytely · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium chloride
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at time of procedure, approximately 45 minutes
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,678 Previous Clinical Trials
21,087,363 Total Patients Enrolled
Darrick K Li, MD, PhDPrincipal InvestigatorYale School of Medicine
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to take bowel preparation and be willing to adhere to the regimen.
You must be aged 18 or greater.
You are scheduled to undergo colonoscopy.
References
- Spadaccini, Marco, Leonardo Frazzoni, Giuseppe Vanella, James East, Franco Radaelli, Cristiano Spada, Lorenzo Fuccio, et al.. 2020. “Efficacy and Tolerability of High- Vs Low-volume Split-dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2019.10.044.
- Patel, Mihir, Estela Staggs, Colleen S. Thomas, Frank Lukens, Michael Wallace, and Cristina Almansa. 2014. “Development and Validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire”. Digestive and Liver Disease. Elsevier BV. doi:10.1016/j.dld.2014.05.020.
- Fuccio, Lorenzo, Leonardo Frazzoni, Cristiano Spada, Alessandro Mussetto, Carlo Fabbri, Mauro Manno, Giovanni Aragona, et al.. 2021. “Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2020.02.055.
- Yadlapati, Rena, Elyse R. Johnston, Dyanna L. Gregory, Jody D. Ciolino, Andrew Cooper, and Rajesh N. Keswani. 2015. “Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs”. Digestive Diseases and Sciences. Springer Science and Business Media LLC. doi:10.1007/s10620-015-3761-2.
- Garber, Ari. 2019. “Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy”. Journal of Hospital Medicine. Wiley. doi:10.12788/jhm.3173.
- Yadlapati, Rena, Elyse R. Johnston, Dyanna L. Gregory, Jody D. Ciolino, Andrew Cooper, and Rajesh N. Keswani. 2015. “Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs”. Digestive Diseases and Sciences. Springer Science and Business Media LLC. doi:10.1007/s10620-015-3761-2.
- Spadaccini M, Frazzoni L, Vanella G, East J, Radaelli F, Spada C, Fuccio L, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Van Hooft JE, Dumonceau JM, Marmo C, Alfieri S, Chandrasekar VT, Sharma P, Rex DK, Repici A, Hassan C. Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1454-1465.e14. doi: 10.1016/j.cgh.2019.10.044. Epub 2019 Nov 1.
- 2022. "MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05054036.
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