Oral Type I Collagen for Relieving Scleroderma
This study has been completed.
Sponsor:
Collaborators:
Wayne State University
University of California, Los Angeles
UTHSC
MUSC
Beth Israel Medical Center
University of Alabama at Birmingham
Johns Hopkins University
Georgetown University
Baltimore VA Medical Center
Northwestern University
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00005675
First received: May 26, 2000
Last updated: May 24, 2010
Last verified: March 2008
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Scleroderma Connective Tissue Diseases |
Drug: Oral bovine type I collagen Drug: Placebo |
Phase 2 |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma |
Resource links provided by NLM:
Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 168 |
| Study Start Date: | April 2000 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive oral bovine type I collagen (CI) daily for 15 months
|
Drug: Oral bovine type I collagen
500 mcg of CI daily for 15 months
Other Name: CI
|
|
Placebo Comparator: 2
Participants will receive placebo daily for 15 months.
|
Drug: Placebo
CI placebo daily for 15 months
|
Detailed Description:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005675
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California Los Angeles | |
| Los Angeles, California, United States, 90024 | |
| United States, Connecticut | |
| University of Connecticut | |
| Farmington, Connecticut, United States, 06030-1310 | |
| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Boston University School Of Medicine | |
| Boston, Massachusetts, United States, 02188 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| University of Tennessee Health Science Center | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| The University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Wayne State University
University of California, Los Angeles
UTHSC
MUSC
Beth Israel Medical Center
University of Alabama at Birmingham
Johns Hopkins University
Georgetown University
Baltimore VA Medical Center
Northwestern University
Investigators
| Principal Investigator: | Arnold E. Postlethwaite, MD | University of Tennessee at Memphis |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Arnold E. Postlethwaite, MD, UTHSC |
| ClinicalTrials.gov Identifier: | NCT00005675 History of Changes |
| Other Study ID Numbers: | N01 AR92242, NIAMS-048 |
| Study First Received: | May 26, 2000 |
| Last Updated: | May 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
Systemic Scleroderma (SSc) Bovine Type I Collagen (CI) Multicenter |
Additional relevant MeSH terms:
|
Connective Tissue Diseases Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013