Expired Study
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Los Angeles, California 90024


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

N01 AR92242


NCT ID:

NCT00005675


Secondary ID:

NIAMS-048


Study Acronym:


Brief Title:

Oral Type I Collagen for Relieving Scleroderma


Official Title:

Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

168


Enrollment Type:

Actual


Overall Contact Information

Official Name:Arnold E. Postlethwaite, MD
Principal Investigator
University of Tennessee at Memphis

Study Dates

Start Date:April 2000
Primary Completion Date:May 2005
Primary Completion Type:Actual
Verification Date:March 2008
Last Changed Date:May 24, 2010
First Received Date:May 26, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests
Time Frame:Measured at Month 12
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Oral bovine type I collagen
Description:500 mcg of CI daily for 15 months
Arm Name:1
Other Name:CI
Intervention Type:Drug
Name:Placebo
Description:CI placebo daily for 15 months
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Participants will receive oral bovine type I collagen (CI) daily for 15 months
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Participants will receive placebo daily for 15 months.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Wayne State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. Review.
PMID:11177772
Reference Type:Reference
Citation:Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. No abstract available.
PMID:15334493

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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