Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT00774969
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2008-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2008-10-16', 'studyFirstSubmitQcDate': '2008-10-16', 'lastUpdatePostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Perianal Crohns'"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the blood levels of Metronidazole after application to the peri anal area after a single dose and 6 or 7 days application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient group:\n\n* Male and female patients with Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.\n* Aged 18-65 years.\n* Have had perianal symptoms for longer than 2 months\n* Have a score of 5 or above in the Perianal Crohn's Disease Activity Index (PCDAI)\n* Have a score of 1 or above on the 'Type of perianal disease' assessment of the PCDAI\n* Subjects can be on concomitant medication. Acceptable regimens are:\n\n * Aminosalicylates at a dosage that has been stable for more than 4 weeks before screening;Infliximab on a stable infusion regimen;\n * Oral corticosteroids \\<40mg per day; Methotrexate, provided that dosage has been stable for more than 4 weeks; azathioprine or mercaptopurine at a dosage that has been stable for more than 8 weeks;\n * Antibiotics at a dosage that has been stable for 4 weeks but excluding metronidazole.\n * Cyclosporin on a stable dose for more than 4 weeks.\n* If patients have setons these must have been in place for at least 4 weeks prior to screening.\n* If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use double-barrier methods of contraception (two separate methods of birth control, one of which may include oral contraception) for the duration of the study.\n* Must have provided written informed consent to participate.\n\nHealthy volunteer group:\n\n* They have had surgery to the anus or rectum in the past 4 weeks.\n* Have a history of inflammatory bowel disease.\n* Allergic to metronidazole.\n* Are taking any prohibited medication.\n* Not prepared to refrain from drinking alcohol during the course of the study.\n* Deemed mentally incompetent.\n* Considered by their physician unlikely to be able to comply with the protocol.\n* Has donated blood within the past 3 months.\n* Taken part in an experimental drug study in the preceding three months.\n\nExclusion Criteria:\n\nPatient group:\n\n* They have had surgery to the anus or rectum in the past 4 weeks.\n* They have a perianal abscess requiring incision and drainage.\n* They have a stoma of less than 6 months duration.\n* Allergic to metronidazole.\n* Are taking any prohibited medication.\n* Not prepared to refrain from drinking alcohol during the course of the study.\n* Deemed mentally incompetent.\n* Considered by their physician unlikely to be able to comply with the protocol.\n* Has donated blood within the past 3 months.\n* Taken part in an experimental drug study in the preceding three months.\n* Has donated blood within the past 3 months.\n* Taken part in an experimental drug study in the preceding three months.\n\nHealthy volunteer group:\n\n* They have had surgery to the anus or rectum in the past 4 weeks.\n* Have a history of inflammatory bowel disease.\n* Allergic to metronidazole.\n* Are taking any prohibited medication.\n* Not prepared to refrain from drinking alcohol during the course of the study.\n* Deemed mentally incompetent.\n* Considered by their physician unlikely to be able to comply with the protocol.\n* Has donated blood within the past 3 months.\n* Taken part in an experimental drug study in the preceding three months."}, 'identificationModule': {'nctId': 'NCT00774969', 'briefTitle': "Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'S.L.A. Pharma AG'}, 'officialTitle': "Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease", 'orgStudyIdInfo': {'id': 'MET/PK/01'}, 'secondaryIdInfos': [{'id': 'EudraCT/IND 2007003173-68'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All', 'description': "6 patients with Perianal Crohn's Disease and 10 healthy Volunteers", 'interventionNames': ['Drug: Metronidazole']}], 'interventions': [{'name': 'Metronidazole', 'type': 'DRUG', 'description': 'Metronidazole 10% ointment three times a day 7 days', 'armGroupLabels': ['All']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Christopher J Jordan, BSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SLA Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.L.A. Pharma AG', 'class': 'INDUSTRY'}}}}