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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01324284

Acronym

Lubiprostone

Enrollment

442

Registered

2011-03-29

Start date

2011-03-31

Completion date

2011-06-30

Last updated

2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma

Keywords

Lubiprostone, Bowel preparation regime

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)

Interventions

DRUGLubiprostone

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026