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Osmotic Laxative

Bowel Prep Regimens for Colonoscopy

Phase 4
Waitlist Available
Led By Yu-Xiao Yang, MD MSCE
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age
Be older than 18 years old
Must not have
Contra-indications to receiving the standard 4L PEG-ELS colonoscopy bowel preparation (e.g., allergy to PEG)
Patients who are <18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month of colonoscopy
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare two commonly used bowel preparations to see which is more effective in leading to the completion of scheduled colonoscopies.

Who is the study for?
This trial is for adults scheduled for outpatient elective colonoscopies who have permission from their provider. It's not for those under 18, inpatients, people with allergies to PEG used in bowel preps, or anyone needing multiple colonoscopies during the study.
What is being tested?
The study compares two bowel cleansing methods before a colonoscopy: Miralax-Gatorade Prep and Golytely. The goal is to see which one leads to more completed procedures and better patient satisfaction within a VA practice setting.
What are the potential side effects?
Possible side effects include nausea, bloating, abdominal discomfort, and dehydration due to the nature of bowel preparations. Both regimens aim at cleaning out the bowels completely before a colonoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or cannot tolerate the standard colonoscopy prep due to health reasons.
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I am under 18 years old.
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I am scheduled for a colonoscopy as an inpatient.
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I need a repeat colonoscopy because my last one had poor bowel prep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month after colonoscopy
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month after colonoscopy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Population level adenoma detection rate (ADR)
colonoscopy completion rate
Secondary study objectives
Adequate bowel prep quality
Intestines
Other study objectives
hyponatremia
Colonoscopy
Kidney Failure

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Miralax-Gatorade prepExperimental Treatment1 Intervention
2-L split-dose Miralax-Gatorade bowel prep
Group II: GolytelyActive Control1 Intervention
4-L split-dose Golytely bowel prep
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene glycol
FDA approved

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,763,605 Total Patients Enrolled
Yu-Xiao Yang, MD MSCEPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Media Library

Golytely (Osmotic Laxative) Clinical Trial Eligibility Overview. Trial Name: NCT03298945 — Phase 4
Colorectal Cancer Research Study Groups: Golytely, Miralax-Gatorade prep
Colorectal Cancer Clinical Trial 2023: Golytely Highlights & Side Effects. Trial Name: NCT03298945 — Phase 4
Golytely (Osmotic Laxative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03298945 — Phase 4
~323 spots leftby Dec 2025
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