Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 12:25 AM
Study NCT ID:
NCT01960569
Status:
UNKNOWN
Last Update Posted:
2013-10-10
First Post:
2013-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-04-06', 'releaseDate': '2017-02-19'}, {'resetDate': '2017-06-23', 'releaseDate': '2017-04-10'}, {'resetDate': '2018-01-30', 'releaseDate': '2017-07-02'}, {'resetDate': '2018-10-26', 'releaseDate': '2018-02-01'}], 'estimatedResultsFirstSubmitDate': '2017-02-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of haematoma', 'timeFrame': '6 months', 'description': 'Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.'}, {'measure': 'Size of oedema', 'timeFrame': '6 months', 'description': 'Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).'}, {'measure': 'Severity of Pain', 'timeFrame': '6 months', 'description': 'Assessment of pain severity will be by Vas score'}, {'measure': 'Change in Colour', 'timeFrame': '6 months', 'description': 'Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thrombexx', 'Topical r-Hirudin', 'Efficacy', 'haematoma'], 'conditions': ['r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas']}, 'referencesModule': {'references': [{'pmid': '30046714', 'type': 'DERIVED', 'citation': 'El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.'}]}, 'descriptionModule': {'briefSummary': 'Single centre ,Phase IV , interventional, The study includes :\n\n200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .\n\nThe patients will be randomized to the active product (arm 1) or to placebo (arm 2).\n\nThe study consists of 4 visits as the following :\n\n* Visit 1 : on day 1 to check patient eligibility and also for randomization .\n* Visit 2 : on day 4 to assess target parameters\n* Visit 3 : on day 8 to assess target parameters\n* Visit 4 : on day 16 to assess target parameters', 'detailedDescription': 'Single centre ,Phase IV , interventional, The study includes :\n\n\\* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .\n\nThe patients will be randomized to the active product (arm 1) or to placebo (arm 2).\n\nThe study consists of 4 visits as the following :\n\n* Visit 1 : on day 1 to check patient eligibility and also for randomization .\n* Visit 2 : on day 4 to assess target parameters\n* Visit 3 : on day 8 to assess target parameters\n* Visit 4 : on day 16 to assess target parameters\n\n * Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema\n * Study duration : 6 months\n * Selection of trial subjects:\n\nInclusion Criteria :\n\n1. Age of patients between 20 and 60 years old.\n2. Patients with all types of haematomas.\n\nExclusion Criteria:\n\n1. Presence of infected wound requiring hospitalization or surgical intervention.\n2. History of allergy or hypersensitivity to any of the ingredients.\n3. Patients with coagulation disorders like haemophilia.\n4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .\n5. Patients who are taking digestive enzymes like alfa chemotrypsin.\n\n * Target parameters :\n\n1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.\n\n2.Size of oedema : by measurement of oedema circumference\n\n3.Pain (by Vas score).\n\n4.Change in colour ( by colour grade scale ) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of patients between 20 and 60 years old.\n* Patients with all types of haematoma.\n\nExclusion Criteria:\n\n* Presence of infected wound requiring hospitalization or surgical intervention.\n* History of allergy or hypersensitivity to any of the ingredients.\n* Patients with coagulation disorders like haemophilia.\n* Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .\n* Patients who are taking digestive enzymes like alfa chemotrypsin.'}, 'identificationModule': {'nctId': 'NCT01960569', 'briefTitle': 'Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'MinaPharm Pharmaceuticals'}, 'officialTitle': 'Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas', 'orgStudyIdInfo': {'id': 'Minpharm07052012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 : active product (Thrombexx)', 'description': '100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment', 'interventionNames': ['Drug: active product ( Thrombexx) assigned to arm 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2 : Placebo', 'description': '100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment', 'interventionNames': ['Other: Placebo assigned to arm 2']}], 'interventions': [{'name': 'active product ( Thrombexx) assigned to arm 1', 'type': 'DRUG', 'otherNames': ['Topical r-Hirudin'], 'description': 'Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete', 'armGroupLabels': ['Arm 1 : active product (Thrombexx)']}, {'name': 'Placebo assigned to arm 2', 'type': 'OTHER', 'armGroupLabels': ['Arm 2 : Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Moneer, Dr', 'role': 'CONTACT', 'email': 'dr_ahmedmoneer@yahoo.com', 'phone': '002 0100 8608676'}, {'name': 'Mahmoud Hafez, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prof. Mahmoud Hafez', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahmoud Hafez, Professor', 'role': 'CONTACT', 'email': 'mhafez@msn.com', 'phone': '002 0100 7566299'}, {'name': 'Moustafa Sameer, Dr', 'role': 'CONTACT', 'email': 'msameer@minapharm.com', 'phone': '002 0100 6016 212'}], 'overallOfficials': [{'name': 'Mahmoud Hafez, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '6th October university'}, {'name': 'Ahmed Moneer, Dr', 'role': 'STUDY_CHAIR', 'affiliation': '6th october university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MinaPharm Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-02-19', 'type': 'RELEASE'}, {'date': '2017-04-06', 'type': 'RESET'}, {'date': '2017-04-10', 'type': 'RELEASE'}, {'date': '2017-06-23', 'type': 'RESET'}, {'date': '2017-07-02', 'type': 'RELEASE'}, {'date': '2018-01-30', 'type': 'RESET'}, {'date': '2018-02-01', 'type': 'RELEASE'}, {'date': '2018-10-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'MinaPharm Pharmaceuticals'}}}}