What side effects are associated with this type of intervention?

Common side effects of low volume bowel preparations like MoviPrep include nausea, vomiting, abdominal pain, bloating, and headache. These side effects are generally less severe compared to high volume preparations such as GoLYTELY, which often result in poor tolerability due to the large volume of liquid required, leading to increased rates of nausea, vomiting, and abdominal discomfort. Both types of preparations aim to ensure adequate bowel cleansing but low volume options are typically better tolerated by patients.

What prior FDA approvals exist?

The FDA has approved several treatments for bowel preparation, including low-volume options like MoviPrep, which is designed to improve tolerability and ensure adequate bowel cleansing. MoviPrep is compared to high-volume preparations like GoLYTELY, which have been traditionally used but are often poorly tolerated by patients. The approval of low-volume preparations like MoviPrep represents a significant advancement in making bowel preparation more manageable for patients, particularly those who are hospitalized or have complex medical conditions.

What other types of research exist?

As of the latest information, there are no specific novel alternatives to MoviPrep mentioned in the provided context. However, the trend towards low volume bowel preparations for improved tolerability and adequate bowel cleansing continues. Patients should consult their healthcare provider for the most current and suitable options available in 2024.

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MoviPrep vs GoLYTELY for Bowel Prep

Phase 4

Waitlist Available

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

Must not have

Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon

Patients undergoing colonoscopy for foreign body removal and/or decompression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of procedure, approximately 45 minutes

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial compares two methods for cleaning out the bowels before a colonoscopy in hospitalized patients. One method uses a smaller amount of liquid, while the other uses a larger amount. The goal is to see if the smaller amount is easier for patients to handle and still effective. This could help reduce delays and shorten hospital stays. The larger amount has been found to be a safe, effective, and well-tolerated method for bowel cleansing in multiple studies.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had major surgery on my intestines or colon.

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I am having a colonoscopy to remove something or relieve pressure.

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I am unable to understand and agree to the study's procedures.

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I am hospitalized with a severe intestinal blockage or swelling.

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I have been diagnosed with phenylketonuria.

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I have a known G6PD deficiency.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal

Secondary study objectives

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

61%

Bloating

40%

Nausea

35%

Abdominal Cramps/Pain

12%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

MiraLAX 357 g (Day-Prior)

MiraLAX 306 g (Day-Prior)

MiraLAX 306 g (Split-Dose)

MoviPrep (Split-Dose)

SUPREP (Split-Dose)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2230

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bowel preparation treatments, such as MoviPrep, work primarily through osmotic and stimulant mechanisms to cleanse the colon. Osmotic agents, like polyethylene glycol (PEG), draw water into the bowel, increasing the water content and volume of the stool, which helps to flush out the intestinal contents. Stimulant laxatives, often included in these preparations, enhance bowel motility by stimulating the intestinal lining. The combination of these actions ensures thorough cleansing of the bowel, which is crucial for clear visibility during colonoscopy. Low volume preparations like MoviPrep are designed to be more tolerable for patients, reducing the volume of liquid they need to consume while still achieving effective bowel cleansing. This improved tolerability can lead to better patient compliance and more successful colonoscopy outcomes.