A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

March 12, 2012 updated by: Southern California Institute for Research and Education

A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822-5201
        • Recruiting
        • VA Long Beach Healthcare System
        • Principal Investigator:
          • Mazen Jamal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years in age
  • Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose

Exclusion Criteria:

  • Allergic to polyethylene glycol
  • Pregnant or lactating
  • Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
  • Congestive Heart Failure NY Heart Assn, Grades III and IV
  • Liver Cirrhosis Childs Pugh Class B or C
  • Serum Creatinine greater than 1.5
  • Previous alimentary tract surgery
  • Ongoing symptoms of abdominal pain, bloating, nausea or constipation
  • Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy
Drug: PEG-ELS (Golytely)
4L consumed evening before colonoscopy
Drug: PEG-ELS (Golytely)
2L consumed on the evening before and 2L consumed on the morning of Colonoscopy
EXPERIMENTAL: Group 2
2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy
Drug: PEG-ELS (Golytely)
4L consumed evening before colonoscopy
Drug: PEG-ELS (Golytely)
2L consumed on the evening before and 2L consumed on the morning of Colonoscopy
EXPERIMENTAL: Group 3
238g of PEG-3350 mixed with 2L of Gatorade
Drug: Miralax mixed with Gatorade
238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
EXPERIMENTAL: Group 4
1L of PEG-3350 + Gatorade
Drug: Miralax
1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Investigators

  • Principal Investigator: Mazen Jamal, MD, VA Long Beach Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (ESTIMATE)

December 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 976

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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