Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

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.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lubiprostone

Drug

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.

Primary outcomes

Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone

Time frame: 2 months

Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: Lubiprostone

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Mar 29, 2011
Registry last updated: Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed