Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT02518568
Status:
TERMINATED
Last Update Posted:
2016-09-28
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma concentration (Cmax)', 'timeFrame': 'up to 24 hours after oral administration'}, {'measure': 'Time to Maximum Concentration (Tmax)', 'timeFrame': 'up to 24 hours after oral administration'}, {'measure': 'Area under the iron plasma concentration curve (AUC)', 'timeFrame': 'up to 24 hours after oral administration'}], 'secondaryOutcomes': [{'measure': 'Tolerability of single administration', 'timeFrame': 'Up to 24 hours', 'description': 'Tolerability by evaluating the number of subjects with emergent adverse events'}]}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18-45 years inclusive with iron deficiency anaemia\n* haemoglobin level between 85 g/L and 105 g/L\n* serum ferritin level \\< 15 µg/L\n* D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation\n\nExclusion Criteria:\n\n* Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,\n* Haemochromatosis or iron overload of secondary origin (blood transfusion),\n* Long term treatment known to modify iron absorption,\n* Gastro duodenal ulcer,\n* Inflammatory bowel disease or any digestive disease which could modify iron absorption,\n* Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),\n* Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.'}, 'identificationModule': {'nctId': 'NCT02518568', 'briefTitle': 'Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.', 'orgStudyIdInfo': {'id': 'V00355 CP 1 02'}, 'secondaryIdInfos': [{'id': '2015-000544-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug', 'interventionNames': ['Drug: V0355']}], 'interventions': [{'name': 'V0355', 'type': 'DRUG', 'description': 'Oral administration (2 tablets)', 'armGroupLabels': ['Drug']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}