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

Bowel Preparation for Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01028573
• Other study ID #: 976
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2009
• Last updated: March 12, 2012
• Start date: November 2009
• Est. completion date: July 2012

Study information

• Verified date: March 2012
• Source: Southern California Institute for Research and Education
• Contact: Mazen Jamal, MD
• Phone: (562) 826-5628
• Email: mazen.jamal[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

Drug:
• PEG-ELS (Golytely)
4L consumed evening before colonoscopy
• PEG-ELS (Golytely)
2L consumed on the evening before and 2L consumed on the morning of Colonoscopy
• Miralax mixed with Gatorade
238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
• Miralax
1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare System	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale		two years	No