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MoviPrep vs GoLYTELY for Bowel Prep

Phase 4

Recruiting

Led By Darrick K Li, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of procedure, approximately 45 minutes

Awards & highlights

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.

Who is the study for?

This trial is for hospitalized adults needing a colonoscopy who can consent, follow the study plan, and take bowel prep. Excluded are those with certain metabolic disorders, prior significant GI surgeries, known allergies to prep ingredients, pregnant or breastfeeding women, and patients with specific GI conditions like ileus.Check my eligibility

What is being tested?

The study compares two types of bowel cleansing methods before a colonoscopy: MoviPrep (low volume) versus GoLYTELY (high volume). It aims to determine if MoviPrep is as effective but more tolerable for inpatients than the traditional high-volume option.See study design

What are the potential side effects?

Possible side effects from both MoviPrep and GoLYTELY may include nausea, vomiting, abdominal pain or cramps, bloating and dehydration. Some people might also experience changes in electrolytes which can affect heart rhythm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of procedure, approximately 45 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of procedure, approximately 45 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of procedure, approximately 45 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal

Secondary outcome measures

BBPS Score During Colonoscopy Withdrawal For Each Segment

Cecal Intubation Rate

Cecal Intubation Time

+6 more

Side effects data

From 2014 Phase 4 trial • 1079 Patients • NCT01719653

63%

Bloating

34%

Abdominal Cramps/Pain

33%

Nausea

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

MiraLAX 306 g (Split-Dose)

MiraLAX 306 g (Day-Prior)

MiraLAX 357 g (Day-Prior)

MoviPrep (Split-Dose)

SUPREP (Split-Dose)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MoviPrepExperimental Treatment1 Intervention

For MoviPrep, the dose, schedule, and route of administration are as follows: On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed. On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy. Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose. Consume only clear liquids from the start of MoviPrep until after the colonoscopy.

Group II: GoLYTELYActive Control1 Intervention

For GoLYTELY, the dose, schedule, and route of administrate are as follows: On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator. Drink the remaining 2 liters on the morning of the procedure. Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete. Avoid red and purple liquids.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MoviPrep

2012

Completed Phase 4

~1710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,218 Total Patients Enrolled

Darrick K Li, MD, PhDPrincipal InvestigatorYale School of Medicine

Media Library

Bowel Preparation Clinical Trial Eligibility Overview. Trial Name: NCT05054036 — Phase 4

Bowel Prep Research Study Groups: MoviPrep, GoLYTELY

Bowel Prep Clinical Trial 2023: Bowel Preparation Highlights & Side Effects. Trial Name: NCT05054036 — Phase 4

Bowel Preparation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054036 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrolment of participants for this trial?

"Affirmative. Clinicaltrials.gov has information that substantiates the recruitment of study participants for this clinical trial, which was first launched on December 1st 2022. The most recent amendment to these documents occurred February 8th 2022 and 450 individuals are required from two research sites."

Answered by AI

Is this research endeavor currently looking for participants?

"Clinicaltrials.gov confirms that as of February 8th, 2022 this trial is still recruiting participants; the endeavour was first listed on December 1st, 2022."

Answered by AI

Is MoviPrep a reliable and innocuous solution for people?

"The safety of MoviPrep has been thoroughly established, so it earned a 3 on the 1-3 scale. This is due to its status as an approved Phase 4 treatment."

Answered by AI

What conditions has MoviPrep been found to alleviate?

"MoviPrep can alleviate the discomfort associated with nasal irritation, eye strain, and pain."

Answered by AI

Are there any historical precedents for using MoviPrep in clinical trials?

"Currently, there are 178 active studies exploring the efficacy of MoviPrep with 34 trials in Phase 3. Primarily based out of Calgary, Alberta, but spanning 893 locations across the world."

Answered by AI