Recruiting

PEG-3350 & PEG-ELS

Sponsor:

Southern California Institute for Research and Education

Code:

NCT01028573

Conditions

Bowel Preparation for Colonoscopy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PEG-ELS (Golytely)

PEG-ELS (Golytely)

Miralax mixed with Gatorade

Miralax

Study Details

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.

Conditions

Bowel Preparation for Colonoscopy

Study ID

NCT01028573

Start date

Nov, 2009

Status verified date

Mar, 2012

Completion date

Jul, 2012

Anticipated

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mazen Jamal, MD

(562) 826-5628mazen.jamal@va.gov

Lea Liu

(562) 826-5058lea.liu@va.gov

Locations

VA Long Beach Healthcare System

Recruiting

Long Beach, California, United States, 90822-5201

Principal Investigator:

Mazen Jamal, MD

More Information

Sponsor

Southern California Institute for Research and Education

Last update posted

Mar 14, 2012

Last verified

Mar, 2012

Keywords

  • bowel preparation
  • colonoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southern California Institute for Research and Education on 2012-03-14.