Evaluation of the Safety of Relaxin in Preeclampsia - Full Text View

Sponsor:	Corthera, Inc.
Information provided by:	Corthera, Inc.
ClinicalTrials.gov Identifier:	NCT00333307

Purpose

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

Condition	Intervention	Phase
Pre-Eclampsia	Drug: recombinant human relaxin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia

Resource links provided by NLM:

Drug Information available for: Methocarbamol Relaxin

U.S. FDA Resources

Further study details as provided by Corthera, Inc.:

Primary Outcome Measures:

maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences

Secondary Outcome Measures:

preeclampsia assessments
vital signs
physical examinations
clinical laboratory assessments

Estimated Enrollment:	18
Study Start Date:	October 2006

Detailed Description:

The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of preeclampsia
Hospital admission for expectant management

Exclusion Criteria:

Eclampsia or history of seizures
Vaginal bleeding
Multifetal gestation
Requirement for immediate delivery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333307

Locations

United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267

Sponsors and Collaborators

Corthera, Inc.

Investigators

Study Director:

Sam Teichman, MD

Corthera, Inc.

More Information

No publications provided

Study ID Numbers:	RLX.PE.001
Study First Received:	June 1, 2006
Last Updated:	March 12, 2010
ClinicalTrials.gov Identifier:	NCT00333307 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Corthera, Inc.:

relaxin
preeclampsia

Additional relevant MeSH terms:

Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Therapeutic Uses
Muscle Relaxants, Central
Methocarbamol

Physiological Effects of Drugs
Pre-Eclampsia
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010