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

Overview

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.

Full Title of Study: “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 Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Diagnostic
  • Masking: Single (Participant)
• Study Primary Completion Date: July 2012

Interventions

• 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

Arms, Groups and Cohorts

• Active Comparator: Group 1
  • 4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy
• Experimental: Group 2
  • 2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy
• Experimental: Group 3
  • 238g of PEG-3350 mixed with 2L of Gatorade
• Experimental: Group 4
  • 1L of PEG-3350 + Gatorade

Clinical Trial Outcome Measures

Primary Measures

• Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
  • Time Frame: two years

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Southern California Institute for Research and Education
• Provider of Information About this Clinical Study
  • M. Mazen Jamal, MD, VA Long Beach Healthcare System
• Overall Official(s)
  • Mazen Jamal, MD, Principal Investigator, VA Long Beach Healthcare System
• Overall Contact(s)
  • Mazen Jamal, MD, (562) 826-5628, mazen.jamal@va.gov