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

University of South Alabama (USA)

Status and phase: Completed; Phase 4

Conditions: Inflammatory Bowel Disease

Treatments: Drug: Placebo; Drug: Lubiprostone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00746395

07-096

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

lubiprostone 24mcg single dose

Active Comparator group

Description:

lubiprostone 24mcg single dose po prior to capsule endoscopy

Treatment:

Drug: Lubiprostone

Sugar pill

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo