Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 7:52 PM
Study NCT ID:
NCT01076803
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C060347', 'term': 'lanreotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of responder patients.', 'timeFrame': 'At day 7 and day 14.'}], 'secondaryOutcomes': [{'measure': 'Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT).', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide'}, {'measure': 'Number of days without vomiting episodes', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide'}, {'measure': 'Number of daily nausea episodes recorded on diary cards.', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide'}, {'measure': 'Intensity of abdominal pain assessed on a visual analogue scale.', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide.'}, {'measure': 'Well-being assessed on a visual analogue scale.', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide.'}, {'measure': 'Time between first injection and clinical response.', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide'}, {'measure': 'Clinical and biological adverse events.', 'timeFrame': 'day 7, day 14 and day 28 after administration of Lanreotide.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malignant intestinal obstruction in inoperable patients'], 'conditions': ['Malignant Intestinal Obstruction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg.\n\n(A responder patient will be defined either as a patient experiencing \\< or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days)\n\nThe total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28\n\nInclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample\n\nVisit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication\n\nIn between the visits, the patient will keep and fill out his diary and VAS scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PIC\n* \\>= 18 years at time of enrolment\n* Diagnosis of a digestive obstruction of malignant origin\n* Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months\n* Inoperability as decided after surgical consultation\n\nExclusion Criteria:\n\n* Operable obstruction\n* Bowel obstruction that can be explained by a non malignant cause\n* Signs of bowel obstruction\n* Prior treatment with somatostatin analogues within the previous 60 days\n* Known hypersensitivity to any of the test materials or related compounds\n* Previous enrolment in this study'}, 'identificationModule': {'nctId': 'NCT01076803', 'briefTitle': 'Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients', 'orgStudyIdInfo': {'id': '2009/289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lanreotide (acetate)', 'interventionNames': ['Drug: Lanreotide (acetate)']}], 'interventions': [{'name': 'Lanreotide (acetate)', 'type': 'DRUG', 'description': 'Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.', 'armGroupLabels': ['Lanreotide (acetate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Karen Geboes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}