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

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746395
• Other study ID #: 07-096
• Status: Completed
• Phase: Phase 4
• Start date: April 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2020
• Source: University of South Alabama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Lubiprostone
24 mcg oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
United States	USA Pavilion at Infirmary West	Mobile	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of South Alabama	Sucampo Pharmaceuticals, Inc., Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Small Bowel Transit	Percent of subjects with capsule passage through small bowel	8 hours
Secondary	Small Bowel Transit	Small bowel transit time	Duration of the test - 8 hours