Inflammatory Bowel Disease
Conditions
Keywords
capsule, endoscopy, prokinetic, lubiprostone, Normal, volunteers
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.
Interventions
DRUGLubiprostone
24 mcg oral administration
DRUGPlacebo
Oral administration
Sponsors
Takeda
Sucampo Pharmaceuticals, Inc.
University of South Alabama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers
Exclusion criteria
* Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Small Bowel Transit | 8 hours | Percent of subjects with capsule passage through small bowel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Small Bowel Transit | Duration of the test - 8 hours | Small bowel transit time |
Countries
United States
Participant flow
Recruitment details
Participants recruited from a specialty clinic in Mobile, AL, USA between April 2008 and September 2008.
Pre-assignment details
45 participants recruited and screened, 1 excluded, 4 withdrew from study.
Participants by arm
| Arm | Count |
|---|---|
| Lubiprostone 24mcg Single Dose lubiprostone 24mcg single dose po prior to capsule endoscopy | 20 |
| Sugar Pill Placebo (sugar pill) - matched single dose po prior to capsule endoscopy | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Sugar Pill | Lubiprostone 24mcg Single Dose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 35.4 years STANDARD_DEVIATION 10.86472 | 38.75 years STANDARD_DEVIATION 13.15045 | 37.07 years STANDARD_DEVIATION 2.36881 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Complete Small Bowel Transit
Percent of subjects with capsule passage through small bowel
Time frame: 8 hours
Population: Placebo 95%, lubiprostone 75%
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubiprostone 24mcg Single Dose | Complete Small Bowel Transit | 75 percentage of subjects with passage |
| Sugar Pill | Complete Small Bowel Transit | 95 percentage of subjects with passage |
Secondary
Small Bowel Transit
Small bowel transit time
Time frame: Duration of the test - 8 hours
Population: Patients without transit to cecum were excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone 24mcg Single Dose | Small Bowel Transit | 188.1 Minutes | Standard Error 68 |
| Sugar Pill | Small Bowel Transit | 218.9 Minutes | Standard Error 89 |