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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):

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

Condition or disease Intervention/treatment Phase
Labor, Induced Drug: Serelaxin Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2005
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Cervical ripening [ Time Frame: Through 24 hours ]

Secondary Outcome Measures :
  1. Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259103


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents