A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
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
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 7, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMarch 14, 2012
March 1, 2012
2.7 years
December 7, 2009
March 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
two years
Study Arms (4)
Group 1
ACTIVE COMPARATOR4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy
Group 2
EXPERIMENTAL2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy
Group 3
EXPERIMENTAL238g of PEG-3350 mixed with 2L of Gatorade
Group 4
EXPERIMENTAL1L of PEG-3350 + Gatorade
Interventions
238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy
Eligibility Criteria
You may qualify if:
- years in age
- Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Long Beach Healthcare System
Long Beach, California, 90822-5201, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Mazen Jamal, MD
VA Long Beach Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 7, 2009
First Posted
December 9, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
March 14, 2012
Record last verified: 2012-03