Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-02 @ 1:55 AM
Study NCT ID:
NCT00746395
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2008-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068238', 'term': 'Lubiprostone'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdipalma@usouthal.edu', 'phone': '251-660-5555', 'title': 'Jack A. DiPalma, M.D.', 'organization': 'University of South Alabama'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study participant enrollment met per protocol requirement.'}}, 'adverseEventsModule': {'timeFrame': 'From the administration of the drug through the end of the procedure.', 'description': 'No serious adverse events during study duration', 'eventGroups': [{'id': 'EG000', 'title': 'Lubiprostone 24mcg Single Dose', 'description': 'lubiprostone 24mcg single dose po prior to capsule endoscopy', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugar Pill', 'description': 'Placebo (sugar pill) - matched single dose po prior to capsule endoscopy', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Small Bowel Transit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24mcg Single Dose', 'description': 'lubiprostone 24mcg single dose po prior to capsule endoscopy'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo (sugar pill) - matched single dose po prior to capsule endoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': 'Percent of subjects with capsule passage through small bowel', 'unitOfMeasure': 'percentage of subjects with passage', 'reportingStatus': 'POSTED', 'populationDescription': 'Placebo 95%, lubiprostone 75%'}, {'type': 'SECONDARY', 'title': 'Small Bowel Transit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24mcg Single Dose', 'description': 'lubiprostone 24mcg single dose po prior to capsule endoscopy'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo (sugar pill) - matched single dose po prior to capsule endoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '188.1', 'spread': '68.0', 'groupId': 'OG000'}, {'value': '218.9', 'spread': '89.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of the test - 8 hours', 'description': 'Small bowel transit time', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without transit to cecum were excluded'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lubiprostone 24mcg Single Dose', 'description': 'lubiprostone 24mcg single dose po prior to capsule endoscopy'}, {'id': 'FG001', 'title': 'Sugar Pill', 'description': 'Placebo (sugar pill) - matched single dose po prior to capsule endoscopy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants recruited from a specialty clinic in Mobile, AL, USA between April 2008 and September 2008.', 'preAssignmentDetails': '45 participants recruited and screened, 1 excluded, 4 withdrew from study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lubiprostone 24mcg Single Dose', 'description': 'lubiprostone 24mcg single dose po prior to capsule endoscopy'}, {'id': 'BG001', 'title': 'Sugar Pill', 'description': 'Placebo (sugar pill) - matched single dose po prior to capsule endoscopy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.75', 'spread': '13.15045', 'groupId': 'BG000'}, {'value': '35.4', 'spread': '10.86472', 'groupId': 'BG001'}, {'value': '37.07', 'spread': '2.36881', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2008-09-03', 'resultsFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-07', 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Small Bowel Transit', 'timeFrame': '8 hours', 'description': 'Percent of subjects with capsule passage through small bowel'}], 'secondaryOutcomes': [{'measure': 'Small Bowel Transit', 'timeFrame': 'Duration of the test - 8 hours', 'description': 'Small bowel transit time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['capsule', 'endoscopy', 'prokinetic', 'lubiprostone', 'Normal', 'volunteers'], 'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '19577749', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea'}, 'identificationModule': {'nctId': 'NCT00746395', 'briefTitle': 'Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of South Alabama'}, 'officialTitle': 'Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy', 'orgStudyIdInfo': {'id': '07-096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lubiprostone 24mcg single dose', 'description': 'lubiprostone 24mcg single dose po prior to capsule endoscopy', 'interventionNames': ['Drug: Lubiprostone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Placebo (sugar pill) - matched single dose po prior to capsule endoscopy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lubiprostone', 'type': 'DRUG', 'otherNames': ['Amitiza'], 'description': '24 mcg oral administration', 'armGroupLabels': ['lubiprostone 24mcg single dose']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Oral administration', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'USA Pavilion at Infirmary West', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'overallOfficials': [{'name': 'JAck A DiPalma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Alabama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Alabama', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}, {'name': 'Sucampo Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}