Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259103
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2005-11-15
Brief Title:
Recombinant Human Relaxin rhRlx in Pregnant Women Scheduled for Induction of Labor
Sponsor:
Corthera Incformerly BAS Medical Inc a member of the Novartis group of companies
Organization:
Corthera Incformerly BAS Medical Inc a member of the Novartis group of companies
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening when compared to a 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None