Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02078856
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2014-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-blind, Randomised Study of A3384 in BAM/BAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Change from Baseline in average severity of diarrhoea during the second treatment week (last 7 days of reporting).\n\n* Change from Baseline in average severity of abdominal discomfort during the second treatment week (last 7 days of reporting).\n* Change from Baseline in average severity of abdominal bloating during the second treatment week (last 7 days of reporting).\n* Change from Baseline in average BSFS during the second treatment week (last 7 days of reporting)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bile Acid Malabsorption']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea\n* Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable\n\nExclusion Criteria:\n\n* Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study\n* Patient needs medications prohibited as specified in the protocol'}, 'identificationModule': {'nctId': 'NCT02078856', 'briefTitle': 'Double-blind, Randomised Study of A3384 in BAM/BAD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Phase II, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3384 in Patients With Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)', 'orgStudyIdInfo': {'id': 'A3384-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A3384 Low dose', 'description': 'Administered twice daily for the duration of the study', 'interventionNames': ['Drug: A3384']}, {'type': 'EXPERIMENTAL', 'label': 'A3384 High dose', 'description': 'Administered twice daily for the duration of the study', 'interventionNames': ['Drug: A3384']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered twice daily for the duration of the study', 'interventionNames': ['Drug: A3384']}], 'interventions': [{'name': 'A3384', 'type': 'DRUG', 'armGroupLabels': ['A3384 High dose', 'A3384 Low dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Academy', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Skövde', 'country': 'Sweden', 'facility': 'Kärnsjukhuset', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.\n\nPatient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albireo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}