NCT00004380

Brief Summary

OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma). II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 1991

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1991

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2004

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Systemic Sclerosis

Keywords

arthritis & connective tissue diseasesrare diseasesystemic sclerosis

Interventions

relaxinDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Progressive systemic sclerosis (scleroderma) * No pregnant or nursing women

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, SystemicArthritisConnective Tissue DiseasesRare Diseases

Interventions

Relaxin

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin DiseasesJoint DiseasesMusculoskeletal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • G. Scott Herron

    Stanford University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

December 1, 1991

Study Completion

December 1, 1997

Last Updated

June 24, 2005

Record last verified: 2004-07