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

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Drug: Placebo; Drug: Lubiprostone

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • USA Pavilion at Infirmary West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lubiprostone 24mcg single dose; lubiprostone 24mcg single dose po prior to capsule endoscopy	Drug: Lubiprostone; 24 mcg oral administration; Other Names: Amitiza
Placebo Comparator: Sugar pill; Placebo (sugar pill) - matched single dose po prior to capsule endoscopy	Drug: Placebo; Oral administration; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Small Bowel Transit	Percent of subjects with capsule passage through small bowel	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Small Bowel Transit	Small bowel transit time	Duration of the test - 8 hours

Collaborators and Investigators

• Sponsor: University of South Alabama
• Collaborators: Takeda; Sucampo Pharmaceuticals, Inc.
• Investigators: Principal Investigator: JAck A DiPalma, MD, University of South Alabama

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 3, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (Estimate): September 4, 2008

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: volunteers; endoscopy; capsule; Normal; lubiprostone; prokinetic
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: 07-096