Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
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ClinicalTrials.gov Identifier: NCT00259103 |
Recruitment Status :
Completed
First Posted : November 29, 2005
Last Update Posted : May 7, 2014
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Sponsor:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Information provided by (Responsible Party):
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Tracking Information | ||||
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First Submitted Date ICMJE | November 15, 2005 | |||
First Posted Date ICMJE | November 29, 2005 | |||
Last Update Posted Date | May 7, 2014 | |||
Study Start Date ICMJE | November 2005 | |||
Actual Primary Completion Date | October 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Cervical ripening [ Time Frame: Through 24 hours ] | |||
Original Primary Outcome Measures ICMJE |
Cervical ripening | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ] | |||
Original Secondary Outcome Measures ICMJE |
Progression to active labor and delivery | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo. | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Labor, Induced | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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;16:260. doi: 10.1186/s12884-016-1046-1. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
72 | |||
Original Enrollment ICMJE |
68 | |||
Actual Study Completion Date ICMJE | October 2006 | |||
Actual Primary Completion Date | October 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Russian Federation | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00259103 | |||
Other Study ID Numbers ICMJE | RLX.CR.001 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies | |||
Study Sponsor ICMJE | Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |