Oral Type I Collagen for Relieving Scleroderma

Completed · Phase 2 · Has a placebo group

Conditions studied: Scleroderma, Connective Tissue Diseases

In brief

Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. The purpose of this study is to determine if taking oral bovine type I collagen (CI) will improve the condition of SSc patients.

Key facts

Study ID

NCT00005675

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

168

Starts

2000-04-01

Last updated by the study team

2010-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of diffuse systemic scleroderma (by American College of Rheumatology criteria 1980) of 10 years or less
• Stable skin involvement by history or physical examination 6 months prior to study entry
• Stable modified Rodnan skin score (MRSS) for 1 month prior to study entry
• Stable MRSS of 16 or more at screening and stable MRSS between screening and baseline visit
• Agree to use acceptable forms of contraception

You may not qualify if…

• Participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry
• Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
• Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as L-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin
• Limited and localized (morphea) or linear SSc
• Tenderness or swelling of the extremities (eosinophilic fasciitis)
• Pregnancy
• Use of certain medications
• Allergy to beef or dairy products
• Nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week before baseline visit. Aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed.
• Use of herbal and some alternative therapies
• Any organ transplant or stem cell transplant

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of Connecticut — Farmington, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University School Of Medicine — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Beth Israel Medical Center — New York, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Virginia Mason Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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