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

NCT ID: NCT01028573

Last Updated: 2012-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy

Group Type ACTIVE_COMPARATOR

PEG-ELS (Golytely)

Intervention Type DRUG

4L consumed evening before colonoscopy

Group 2

2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy

Group Type EXPERIMENTAL

PEG-ELS (Golytely)

Intervention Type DRUG

2L consumed on the evening before and 2L consumed on the morning of Colonoscopy

Group 3

238g of PEG-3350 mixed with 2L of Gatorade

Group Type EXPERIMENTAL

Miralax mixed with Gatorade

Intervention Type DRUG

238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy

Group 4

1L of PEG-3350 + Gatorade

Group Type EXPERIMENTAL

Miralax

Intervention Type DRUG

1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

Interventions

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PEG-ELS (Golytely)

4L consumed evening before colonoscopy

Intervention Type DRUG

PEG-ELS (Golytely)

2L consumed on the evening before and 2L consumed on the morning of Colonoscopy

Intervention Type DRUG

Miralax mixed with Gatorade

238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy

Intervention Type DRUG

Miralax

1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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VA Long Beach Healthcare System

Principal Investigators

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Mazen Jamal, MD

Role: PRINCIPAL_INVESTIGATOR

VA Long Beach Healthcare System

Locations

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VA Long Beach Healthcare System

Long Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mazen Jamal, MD

Role: CONTACT

(562) 826-5628

Lea Liu

Role: CONTACT

(562) 826-5058

Other Identifiers

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976

Identifier Type: -

Identifier Source: org_study_id

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