Trial | NCT01324284  Report issue

Title

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    442
Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.
Objectives:

Primary:

Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with Lubiprostone (Arm 2)
Waiting time for colonoscopic procedure and quality of bowel preparation

Secondary:

Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)
Study Started
Mar 31
2011
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Apr 05
2013
Estimate

Drug Lubiprostone

Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.

Lubiprostone Experimental

Lubiprostone with PEG solution versus Placebo with PEG solution

lubiprostone versus placebo Placebo Comparator

Criteria 

Inclusion Criteria:

All adult patient referred for colonoscopy to AIG
Age 18 - 75 years old

Exclusion Criteria:

Acute GI bleeding.
Patient of bowel preparation regime other than excepted for the study.
Renal insufficiency.
Dementia.
Symptomatic heart failure.
Recent Myocardial Infarction.
Patients with ileus.
Suspected bowel obstruction.
Prior alimentary tract surgery.
Significant gastroparesis.
Gastric outlet obstruction.
Toxic colitis or megacolon.
Pregnant or lactating patients.
No Results Posted