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

Phase 2 Completed 72 enrolled Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2005-11
Primary completion: 2006-10
Completion: 2006-10

Outcome

Missed primary endpoint

paper There were no significant differences between the groups receiving the highest safe dose of serelaxin (75 μg/kg/day) and placebo in the primary or secondary efficacy endpoints. PMID 27596360 ↗

paper Changes from baseline in Bishop score at 24 h were 4.19 ± 1.9 and 3.26 ± 2.26 in the pooled placebo and serelaxin groups, respectively (p = 0.2507). PMID 27596360 ↗

Publications

Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Serelaxin	Protein / enzyme biologic	7.5 ug/kg	Intravenous
Subject	Serelaxin	Protein / enzyme biologic	25 ug/kg	Intravenous
Subject	Serelaxin	Protein / enzyme biologic	75 ug/kg	Intravenous

Indications

No indication recorded.