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

Labor, Induced Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259103
• Other study ID #: RLX.CR.001
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2005
• Last updated: May 6, 2014
• Start date: November 2005
• Est. completion date: October 2006

Study information

• Verified date: May 2014
• Source: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Labor, Induced

Intervention

Drug:
• Serelaxin

• Placebo

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical ripening		Through 24 hours	No
Secondary	Progression to active labor and delivery		Within 7 Days of Drug Infusion	No