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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
| Sucampo Pharmaceuticals, Inc. | INDUSTRY |
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This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lubiprostone 24mcg single dose | Active Comparator | lubiprostone 24mcg single dose po prior to capsule endoscopy |
|
| Sugar pill | Placebo Comparator | Placebo (sugar pill) - matched single dose po prior to capsule endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | 24 mcg oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Small Bowel Transit | Percent of subjects with capsule passage through small bowel | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Small Bowel Transit | Small bowel transit time | Duration of the test - 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JAck A DiPalma, MD | University of South Alabama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Pavilion at Infirmary West | Mobile | Alabama | 36693 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19577749 | Derived | 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. |
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45 participants recruited and screened, 1 excluded, 4 withdrew from study.
Participants recruited from a specialty clinic in Mobile, AL, USA between April 2008 and September 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone 24mcg Single Dose | lubiprostone 24mcg single dose po prior to capsule endoscopy |
| FG001 | Sugar Pill | Placebo (sugar pill) - matched single dose po prior to capsule endoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone 24mcg Single Dose | lubiprostone 24mcg single dose po prior to capsule endoscopy |
| BG001 | Sugar Pill | Placebo (sugar pill) - matched single dose po prior to capsule endoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Small Bowel Transit | Percent of subjects with capsule passage through small bowel | Placebo 95%, lubiprostone 75% | Posted | Number | percentage of subjects with passage | 8 hours |
|
From the administration of the drug through the end of the procedure.
No serious adverse events during study duration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubiprostone 24mcg Single Dose | lubiprostone 24mcg single dose po prior to capsule endoscopy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
Study participant enrollment met per protocol requirement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack A. DiPalma, M.D. | University of South Alabama | 251-660-5555 | jdipalma@usouthal.edu |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Placebo | Drug | Oral administration |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Small Bowel Transit | Small bowel transit time | Patients without transit to cecum were excluded | Posted | Mean | Standard Error | Minutes | Duration of the test - 8 hours |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Sugar Pill | Placebo (sugar pill) - matched single dose po prior to capsule endoscopy | 0 | 20 | 1 | 20 |
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| D008055 |
| Lipids |
| D002241 | Carbohydrates |