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

May 6, 2014 updated by: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation
        • Novosibirsk State Medical Academy
      • Saint Petersburg, Russian Federation, 199034
        • Evidence CPR
      • Saint Petersburg, Russian Federation
        • D.O. Ott Research Institute of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cervical ripening
Time Frame: Through 24 hours
Through 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression to active labor and delivery
Time Frame: Within 7 Days of Drug Infusion
Within 7 Days of Drug Infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RLX.CR.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor, Induced

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe