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
  Purpose

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


Condition Intervention Phase
Labor, Induced
Drug: Serelaxin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:

Primary Outcome Measures:
  • Cervical ripening [ Time Frame: Through 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7.5 µg/kg/d
Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.
Drug: Serelaxin
Experimental: 25 µg/kg/d
Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.
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.
Drug: Serelaxin
Experimental: Placebo
Participants who received IV infusion of placebo, some during part A and others during part B.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259103

Locations
Russian Federation
Novosibirsk State Medical Academy
Novosibirsk, Russian Federation
D.O. Ott Research Institute of Obstetrics and Gynecology
Saint Petersburg, Russian Federation
Evidence CPR
Saint Petersburg, Russian Federation, 199034
Sponsors and Collaborators
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Investigators
Study Director: Sam Teichman, MD Chief Medical Officer of BAS Medical, Inc.
  More Information

No publications provided

Responsible Party: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier: NCT00259103     History of Changes
Other Study ID Numbers: RLX.CR.001
Study First Received: November 15, 2005
Last Updated: May 6, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:
relaxin
pregnancy
cervical ripening
normal pregnancy at least at 40 weeks of gestation

ClinicalTrials.gov processed this record on August 28, 2014