Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

NCT ID: NCT00746395

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-09-30

Brief Summary

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

Detailed Description

Introduction of small bowel capsule endoscopy made available an unique technique for diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides small bowel yield. Capsule endoscopy has special application for evaluation of inflammation bowel disease and other small bowel conditions. Several adjuncts are used to enhance the examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod, simethicone, erythromycin, phosphates and polyethylene glycol (PEG) colon cleansing agents have been tried and some show improved visualization or increased propulsion where more capsules reach to colonic cecum while still recording within the limits of its 8 hour battery. Recently, our group had an observational report of our experience showing that either full bowel cleansing preparation or prokinetics such as metoclopramide or tegaserod enhanced visualization and functioning capsule transit to the colon. Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation.

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose was chosen because other medications used in similar single dose in our pilot studies appear effective.

Conditions

Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

lubiprostone 24mcg single dose

lubiprostone 24mcg single dose po prior to capsule endoscopy

Group Type: ACTIVE_COMPARATOR

Lubiprostone

Intervention Type: DRUG

24 mcg oral administration

Sugar pill

Placebo (sugar pill) - matched single dose po prior to capsule endoscopy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration

Interventions

Lubiprostone

24 mcg oral administration

Intervention Type: DRUG

Placebo

Oral administration

Intervention Type: DRUG

Other Intervention Names

Amitiza; Sugar pill

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Sucampo Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of South Alabama

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JAck A DiPalma, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama

Locations

USA Pavilion at Infirmary West

Mobile, Alabama, United States

Countries

United States

References

Hooks SB 3rd, Rutland TJ, Di Palma JA. Lubiprostone neither decreases gastric and small-bowel transit time nor improves visualization of small bowel for capsule endoscopy: a double-blind, placebo-controlled study. Gastrointest Endosc. 2009 Nov;70(5):942-6. doi: 10.1016/j.gie.2009.04.045. Epub 2009 Jul 4.

Reference Type: DERIVED

PMID: 19577749 (View on PubMed)

Other Identifiers

07-096

Identifier Type: -

Identifier Source: org_study_id