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Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00259103
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Tracking Information
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
 (submitted: May 6, 2014)		 Cervical ripening [ Time Frame: Through 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)		 Cervical ripening
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)		 Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)		 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
Condition  ICMJE Labor, Induced
Intervention  ICMJE
  • Drug: Serelaxin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 7.5 µg/kg/d
    Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.
    Intervention: Drug: Serelaxin
  • Experimental: 25 µg/kg/d
    Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.
    Intervention: Drug: Serelaxin
  • Experimental: 75 µg/kg/d
    Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.
    Intervention: Drug: Serelaxin
  • Experimental: Placebo
    Participants who received IV infusion of placebo, some during part A and others during part B.
    Intervention: Drug: Placebo
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2014)		 72
Original Enrollment  ICMJE
 (submitted: November 28, 2005)		 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:

  • Age between 18 and 40 years
  • Normal pregnancy
  • At least 40 weeks of gestation
  • Otherwise healthy

Exclusion Criteria:

  • Anemia or hypertension
  • Presence of chronic disease
  • Endometriosis
  • Known fetal anomaly
  • Substance abuse
  • History of cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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
Study Director: Sam Teichman, MD Chief Medical Officer of BAS Medical, Inc.
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