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

NCT01324284 | Completed Phase 3

• 1 other identifier: AIG-GI2011-01
• Study Type: interventional
• Target: 442
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Carcinoma

Keywords

Lubiprostone; Bowel preparation regime

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lubiprostone

EXPERIMENTAL

Lubiprostone with PEG solution versus Placebo with PEG solution

Drug: Lubiprostone

lubiprostone versus placebo

PLACEBO COMPARATOR

Interventions

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.

Lubiprostone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Related Publications (1)

• Banerjee R, Chaudhari H, Shah N, Saravanan A, Tandan M, Reddy DN. Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2016 Oct 13;16(1):133. doi: 10.1186/s12876-016-0542-0.

  PMID: 27737636 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Nageshwar D Reddy, MD. DM

  Asian Institute of Gastroenterolgy India

  STUDY DIRECTOR

• Rupa Banerjee, MD

  Asian Institute of Gastroenterology, India

  PRINCIPAL INVESTIGATOR

• Saravanan Arjunan, MD

  Asian Institute of Gastroenterology, India

  PRINCIPAL INVESTIGATOR

• Manu Tandan, MD DM

  AIG Hyderabad india

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant gastroenterologist

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 29, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 5, 2013

Record last verified: 2013-04