Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT01483833
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2011-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Iferanserin to Treat Hemorrhoids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572904', 'term': 'iferanserin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of hemorrhoid bleeding', 'timeFrame': 'Day 7 and 14', 'description': 'Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study.'}], 'secondaryOutcomes': [{'measure': 'Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.', 'timeFrame': '14 days', 'description': 'Change from pre-treatment in patient assessment of bleeding on other treatment days, change from pre-treatment in hemorrhoid size, change from pre-treatment in patient assessment of other hemorrhoid symptoms/conditions on all treatment days, and physician evaluation of hemorrhoids at the end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemorrhoids']}, 'referencesModule': {'references': [{'pmid': '22244049', 'type': 'DERIVED', 'citation': 'Herold A, Dietrich J, Aitchison R. Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Feb;34(2):329-40. doi: 10.1016/j.clinthera.2011.12.012. Epub 2012 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.\n* Patients signing the Informed Consent form.\n\nExclusion Criteria:\n\n* Patients with protruding or irreducible hemorrhoids (grade IV).\n* Patients with anal fistulas, periproctitis or hemorrhagic diathesis\n* Patients with current history of Type I or Type II diabetes mellitus.\n* Patients with severe hepatic, renal or cardiovascular disorders.\n* Patients with any type of infectious disease.\n* Patients who have been involved with another experimental drug trial within the past 30 days.\n* Patients presently diagnosed with cancer.\n* Patients who have known alcohol and drug abuse.\n* Patients who require the use of suppositories.\n* Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT01483833', 'briefTitle': 'Efficacy Study of Iferanserin to Treat Hemorrhoids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ventrus Biosciences, Inc'}, 'officialTitle': 'Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids', 'orgStudyIdInfo': {'id': 'VEN309-SMPEC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Iferanserin', 'description': 'Iferanserin administration intra-anally twice daily for 14 days', 'interventionNames': ['Drug: Iferanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administration intra-anally twice daily for 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Iferanserin', 'type': 'DRUG', 'otherNames': ['VEN309'], 'description': 'Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days', 'armGroupLabels': ['Iferanserin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo ointment applied intra-anally twice daily for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mannheim', 'country': 'Germany', 'facility': 'Prof. Alexander Herold, MD', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ventrus Biosciences, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}