Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT00259103
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2005-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C577649', 'term': 'serelaxin protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2005-11-15', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical ripening', 'timeFrame': 'Through 24 hours'}], 'secondaryOutcomes': [{'measure': 'Progression to active labor and delivery', 'timeFrame': 'Within 7 Days of Drug Infusion'}]}, 'conditionsModule': {'keywords': ['relaxin', 'pregnancy', 'cervical ripening', 'normal pregnancy at least at 40 weeks of gestation'], 'conditions': ['Labor, Induced']}, 'referencesModule': {'references': [{'pmid': '27596360', 'type': 'DERIVED', 'citation': 'Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.', 'detailedDescription': 'A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 40 years\n* Normal pregnancy\n* At least 40 weeks of gestation\n* Otherwise healthy\n\nExclusion Criteria:\n\n* Anemia or hypertension\n* Presence of chronic disease\n* Endometriosis\n* Known fetal anomaly\n* Substance abuse\n* History of cancer'}, 'identificationModule': {'nctId': 'NCT00259103', 'briefTitle': 'Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies'}, 'officialTitle': 'A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labour', 'orgStudyIdInfo': {'id': 'RLX.CR.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7.5 µg/kg/d', 'description': 'Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.', 'interventionNames': ['Drug: Serelaxin']}, {'type': 'EXPERIMENTAL', 'label': '25 µg/kg/d', 'description': 'Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.', 'interventionNames': ['Drug: Serelaxin']}, {'type': 'EXPERIMENTAL', 'label': '75 µg/kg/d', 'description': 'Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.', 'interventionNames': ['Drug: Serelaxin']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants who received IV infusion of placebo, some during part A and others during part B.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Serelaxin', 'type': 'DRUG', 'armGroupLabels': ['25 µg/kg/d', '7.5 µg/kg/d', '75 µg/kg/d']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Novosibirsk State Medical Academy', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '199034', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Evidence CPR', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'D.O. Ott Research Institute of Obstetrics and Gynecology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Sam Teichman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Medical Officer of BAS Medical, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}