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

Phase 3

Completed

• Conditions: Colorectal Carcinoma
• Interventions: Drug: Lubiprostone

• Registration Number: NCT01324284
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

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.

Detailed Description

Objectives:

1. 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

2. Secondary:

* Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

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

Exclusion Criteria

1. Acute GI bleeding.
2. Patient of bowel preparation regime other than excepted for the study.
3. Renal insufficiency.
4. Dementia.
5. Symptomatic heart failure.
6. Recent Myocardial Infarction.
7. Patients with ileus.
8. Suspected bowel obstruction.
9. Prior alimentary tract surgery.
10. Significant gastroparesis.
11. Gastric outlet obstruction.
12. Toxic colitis or megacolon.
13. Pregnant or lactating patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lubiprostone	Lubiprostone	Lubiprostone with PEG solution versus Placebo with PEG solution

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone	2 months	Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)