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

This study is currently recruiting participants.

Verified March 2012 by Southern California Institute for Research and Education

Sponsor:

Information provided by:

Southern California Institute for Research and Education

ClinicalTrials.gov Identifier:

NCT01028573

First received: December 7, 2009

Last updated: March 12, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2009

Last Updated Date

March 12, 2012

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Condition ^ICMJE

Bowel Preparation for Colonoscopy

Intervention ^ICMJE

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
Drug: Miralax mixed with Gatorade
238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
Drug: Miralax
1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

Study Arm (s)

Active Comparator: Group 1
4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy

Intervention: Drug: PEG-ELS (Golytely)
Experimental: Group 2
2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy

Intervention: Drug: PEG-ELS (Golytely)
Experimental: Group 3
238g of PEG-3350 mixed with 2L of Gatorade

Intervention: Drug: Miralax mixed with Gatorade
Experimental: Group 4
1L of PEG-3350 + Gatorade

Intervention: Drug: Miralax

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mazen Jamal, MD	(562) 826-5628	mazen.jamal@va.gov
Contact: Lea Liu	(562) 826-5058	lea.liu@va.gov

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01028573

Other Study ID Numbers ^ICMJE

976

Has Data Monitoring Committee

Responsible Party

M. Mazen Jamal, MD, VA Long Beach Healthcare System

Study Sponsor ^ICMJE

Southern California Institute for Research and Education

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mazen Jamal, MD

VA Long Beach Healthcare System

Information Provided By

Southern California Institute for Research and Education

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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