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Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT00004380
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: relaxin Phase 2

Detailed Description:
PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Study Start Date : December 1991
Estimated Study Completion Date : December 1997

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Progressive systemic sclerosis (scleroderma)
  • No pregnant or nursing women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004380

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Stanford University
Study Chair: G. Scott Herron Stanford University
More Information

ClinicalTrials.gov Identifier: NCT00004380     History of Changes
Other Study ID Numbers: 199/12015
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2004

Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
rare disease
systemic sclerosis

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents