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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Southern California Institute for Research and Education.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01028573
First received: December 7, 2009
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Bowel Preparation for Colonoscopy
Drug: PEG-ELS (Golytely)
Drug: Miralax mixed with Gatorade
Drug: Miralax

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

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: November 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy
Drug: PEG-ELS (Golytely)
4L consumed evening before colonoscopy
Experimental: Group 2
2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy
Drug: PEG-ELS (Golytely)
2L 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
Drug: Miralax mixed with Gatorade
238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
Experimental: Group 4
1L of PEG-3350 + Gatorade
Drug: Miralax
1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028573

Contacts
Contact: Mazen Jamal, MD (562) 826-5628 mazen.jamal@va.gov
Contact: Lea Liu (562) 826-5058 lea.liu@va.gov

Locations
United States, California
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822-5201
Principal Investigator: Mazen Jamal, MD         
Sponsors and Collaborators
Southern California Institute for Research and Education
Investigators
Principal Investigator: Mazen Jamal, MD VA Long Beach Healthcare System
  More Information

No publications provided

Responsible Party: M. Mazen Jamal, MD, VA Long Beach Healthcare System
ClinicalTrials.gov Identifier: NCT01028573     History of Changes
Other Study ID Numbers: 976
Study First Received: December 7, 2009
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
bowel preparation
colonoscopy

ClinicalTrials.gov processed this record on September 18, 2014