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Home > "O" Clinical Trials Conditions > Oral Type I Collagen for Relieving Scleroderma  Oral Type I Collagen for Relieving Scleroderma
Oral Type I Collagen for Relieving Scleroderma
For Condition: Scleroderma,Connective Tissue Diseases
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: SSc is a chronic connective tissue disease that is caused by excess collagen deposits that damage the skin and other organs. This study will determine if a daily oral dose of bovine CI will improve the condition of patients with SSc. Patients will be randomly assigned to one of two groups. The first group will receive 500 mcg bovine CI daily for 15 months; the second group will receive placebo. Study visits will be conducted at Months 4, 8, 12, and 15. Patients will undergo physical examination and blood tests at each visit. Patients will also be evaluated for modified Rodnan skin score (MRSS) and will be given health assessment questionnaires. A chest x-ray will be conducted at study entry and pulmonary function tests will be conducted at study entry and Month 12.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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 Exclusion Criteria: - 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
Total Enrollment: 168
Location and Contact Information:
Overall Study Official:
ArnoldPostlethwaite, Principal Investigator, University of Tennessee at Memphis
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Boston University School Of Medicine
Boston, Massachusetts, 02188
United States
University of California Los Angeles
Los Angeles, California, 90024
United States
University of Connecticut
Farmington, Connecticut, 06030-1310
United States
Johns Hopkins University
Baltimore, Maryland, 21224
United States
Beth Israel Medical Center
New York City, New York, 10003
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Wayne State University
Detroit, Michigan, 48201
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Additional Information:
Study ID Numbers: NIAMS-048; N01 AR-9-2242
Study Start Date: April 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005675
Other Scleroderma Studies:
1. Study of Silicone-Associated Connective Tissue Diseases
2. Phase II Study of Methylprednisolone and Xylose Absorption in Children with Hypersensitivity Vasculitis Associated with Connective Tissue Disease
3. Oral Type I Collagen for Relieving Scleroderma
Related Studies:
Other Scleroderma Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Oral Type I Collagen for Relieving Scleroderma
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