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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
Scheduled for outpatient elective screening, surveillance or diagnostic colonoscopies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month after colonoscopy
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I am scheduled for a routine or diagnostic colonoscopy.

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

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

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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,604 Previous Clinical Trials
3,303,310 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

Frequently Asked Questions

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

Are participants currently being recruited for this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this medical trial, which was initiated on December 13th of 2018, is actively recruiting participants. About 10,000 individuals need to be recruited at a single location."

Answered by AI

Are there other experiments that have been conducted utilizing Miralax-Gatorade Prep?

"Currently, there is a flurry of clinical trials studying the efficacy of Miralax-Gatorade Prep; out of these 128 active studies, 26 are in Phase 3. The bulk of them take place within Calgary, Alberta however 424 different sites across the globe have taken part in this research initiative."

Answered by AI

Has the FDA sanctioned Miralax-Gatorade Prep as a viable medical regimen?

"The safety of Miralax-Gatorade Prep has been deemed satisfactory and is assigned a rating of 3 due to Phase 4 trials having revealed its efficacy."

Answered by AI

To what ailment is Miralax-Gatorade Prep typically prescribed?

"Miralax-Gatorade Prep is generally used as a remedy for increased intra ocular pressure, though it also proves effective in ameliorating nasal irritation and augmenting renal excretion of certain harmful elements."

Answered by AI

What is the maximum number of participants in this experiment?

"Affirmative. Information on clinicaltrials.gov confirms that this medical experiment, which was initially announced on December 13th 2018, is actively recruiting people to participate in the study. Approximately 10,000 participants need to be enrolled from 1 site."

Answered by AI
~362 spots leftby Mar 2025