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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier:
NCT00259103
First received: November 15, 2005
Last updated: May 6, 2014
Last verified: May 2014

November 15, 2005
May 6, 2014
November 2005
October 2006   (final data collection date for primary outcome measure)
Cervical ripening [ Time Frame: Through 24 hours ] [ Designated as safety issue: No ]
Cervical ripening
Complete list of historical versions of study NCT00259103 on ClinicalTrials.gov Archive Site
Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ] [ Designated as safety issue: No ]
Progression to active labor and delivery
Not Provided
Not Provided
 
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
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

The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Labor, Induced
  • Drug: Serelaxin
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00259103
RLX.CR.001
Not Provided
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Not Provided
Study Director: Sam Teichman, MD Chief Medical Officer of BAS Medical, Inc.
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP