A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
Information source: Southern California Institute for Research and Education
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bowel Preparation for Colonoscopy
Intervention: PEG-ELS (Golytely) (Drug); PEG-ELS (Golytely) (Drug); Miralax mixed with Gatorade (Drug); Miralax (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Southern California Institute for Research and Education Official(s) and/or principal investigator(s): Mazen Jamal, MD, Principal Investigator, Affiliation: VA Long Beach Healthcare System
Overall contact: Mazen Jamal, MD, Phone: (562) 826-5628, Email: mazen.jamal@va.gov
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Primary outcome: Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mazen Jamal, MD, Phone: (562) 826-5628, Email: mazen.jamal@va.gov
VA Long Beach Healthcare System, Long Beach, California 90822-5201, United States; Recruiting Mazen Jamal, MD, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: March 12, 2012
|