Clinical Trials Directory

Trials / Completed

CompletedNCT00704665

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
231 (actual)
Sponsor
University of Medicine and Dentistry of New Jersey · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.

Conditions

Interventions

TypeNameDescription
DRUGRelaxin10 ug/kg/day or 25 ug/kg/day
DRUGRelaxinPlacebo

Timeline

Start date
1998-12-01
Primary completion
2001-12-01
Completion
2001-12-01
First posted
2008-06-25
Last updated
2008-06-25

Source: ClinicalTrials.gov record NCT00704665. Inclusion in this directory is not an endorsement.

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma (NCT00704665) · Clinical Trials Directory