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

Colorectal Carcinoma Clinical Trial

— Lubiprostone  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324284
• Other study ID #: AIG-GI2011-01
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2011
• Last updated: April 4, 2013
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Carcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone	Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)	2 months	Yes