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

S

Southern California Institute for Research and Education

Status

Unknown

Conditions

Bowel Preparation for Colonoscopy

Treatments

Drug: PEG-ELS (Golytely)
Drug: Miralax mixed with Gatorade
Drug: Miralax

Study type

Interventional

Funder types

Other

Identifiers

NCT01028573
976

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 4 patient groups

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

Trial contacts and locations

1

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Central trial contact

Lea Liu; Mazen Jamal, MD

Data sourced from clinicaltrials.gov

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