80 Participants Needed

SUPREP vs Golytely for Colon Cancer Screening

DF
Overseen ByDarrell F Barker MD, FACG, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Eisenhower Army Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two bowel cleansing treatments, Golytely and SUPREP, to determine which is more effective for colon cancer screening in people with diabetes. Researchers aim to identify any differences in bowel cleansing efficacy and patient tolerability between the treatments. Participants will be randomly assigned to use one of the two preparations before their colonoscopy. The trial seeks diabetic adults undergoing routine colon cancer screening with no history of colorectal surgery or inflammatory bowel disease. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for Golytely and SUPREP?

Research has shown that both Golytely and SUPREP are safe options for bowel cleansing before a colonoscopy. Studies suggest that SUPREP might be more effective and easier to tolerate than Golytely. Both are widely used, and most people tolerate them well.

One study found that SUPREP is less likely to result in an incomplete bowel prep compared to Golytely, making it potentially easier for some people to use. Another study found no major differences in safety between the two. Both are common choices for colonoscopy prep, and serious side effects are rare.

While both are generally safe, individual experiences can vary. Participants should discuss any concerns with their healthcare provider.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because SUPREP and Golytely offer distinct approaches to bowel preparation for colonoscopy, particularly for diabetic patients. Unlike the standard options, which often include polyethylene glycol solutions like Golytely, SUPREP is sulfate-based, potentially offering a more tolerable taste and better patient compliance. These differences could lead to improved preparation quality and a more comfortable experience for patients, which is crucial for effective colon cancer screening. By exploring these alternatives, researchers hope to enhance the overall effectiveness and acceptance of colonoscopy procedures.

What evidence suggests that this trial's treatments could be effective for bowel cleansing in diabetic patients?

In this trial, diabetic patients will prepare for screening colonoscopy using either SUPREP or Golytely. Previous studies have shown that SUPREP effectively cleans the colon before a colonoscopy. Specifically, research found that patients using SUPREP had a 48% lower chance of an inadequately cleaned colon compared to those using Golytely. This suggests that SUPREP generally prepares the colon better for the procedure. The FDA has approved SUPREP for colon cleansing, supporting its effectiveness. While Golytely is also effective, SUPREP might be easier for patients to tolerate, making it more comfortable to use.12346

Are You a Good Fit for This Trial?

This trial is for diabetic patients who need a colonoscopy to screen for colon cancer. Participants will be randomly assigned to use either Golytely or SUPREP bowel prep. They must complete a tolerability form and undergo the screening where a doctor, unaware of which prep they used, scores the cleanliness of their bowels.

Inclusion Criteria

Participants having provided informed consent with signature on informed consent form after full discussion of all requirements and possible risks
Diabetic volunteer as defined per current ACP guidelines, any type of DM
I am 18 years old or older.
See 1 more

Exclusion Criteria

I am able to understand and consent to participate in the study.
Prior use of any investigational drug in the preceding 6 months
Pregnant or breast-feeding women or those planning to become pregnant during the study
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants are randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy

1 day
1 visit (in-person)

Colonoscopy Procedure

Participants undergo a standardized screening colonoscopy during which a blinded endoscopist will document the participant's BBPS

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedural effects and tolerability is assessed using the Mayo Bowel Prep Tolerability Form

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Golytely
  • SUPREP

Trial Overview

The study compares two bowel cleansing methods—Golytely and SUPREP—to see which one works better for diabetics before a colonoscopy. It measures how well each cleans out the bowels using the Boston Bowel Prep Score and checks patient comfort with the Mayo Bowel Prep Tolerability Form.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Diabetic patients undergoing bowel prep for screening colonoscopy using GolytelyActive Control1 Intervention
Group II: Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREPActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eisenhower Army Medical Center

Lead Sponsor

Trials
9
Recruited
720+

Citations

Comparative Effectiveness of Commercial Bowel Preparations ...

After adjusting for these factors, compared to GoLYTELY, patients receiving SuPREP and NuLYTELY had 48% and 35% reduced odds of having IBP.

NCT02523911 | Efficacy and Tolerability of Suprep With ...

The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient ...

NDA/BLA Multi-Disciplinary Review and Evaluation ( ...

approval of Suprep Bowel Prep Kit for cleansing of the colon in preparation for colonoscopy in ... • The safety and effectiveness of Suprep Bowel ...

Optimizing Bowel Preparation Quality for Colonoscopy

This document is an update to the 2014 recommendations for optimizing the adequacy of bowel cleansing for colonoscopy from the US Multi-Society ...

Impact of Bowel Preparation Quality on Colonoscopy ...

Overall, 125,439 (37%) colonoscopies had excellent bowel preparation, 159,719 (48%) had good bowel preparation, 37,943 (11%) had fair bowel preparation, 9,440 ( ...

554 Comparative Effectiveness of Colonoscopy Bowel ...

Our data suggests Golytely® is not as effective as other 4L PEG solutions, Moviprep® or Suprep®. In an era where reimbursement is tied to quality, using the ...