Oral Type I Collagen for Relieving Scleroderma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00005675
• Date of registration: 26/05/2000
• Prospective Registration: No
• Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Public title: Oral Type I Collagen for Relieving Scleroderma
• Scientific title: Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma
• Date of first enrolment: April 2000
• Target sample size: 168
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00005675
• 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
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Arnold E. Postlethwaite, MD
• Affiliation: University of Tennessee at Memphis

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Scleroderma

Connective Tissue Diseases

Intervention(s)

Drug: Oral bovine type I collagen

Drug: Placebo

Primary Outcome(s)

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]

Secondary ID(s)

NIAMS-048

N01 AR92242

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Johns Hopkins University

Wayne State University

University of California, Los Angeles

Beth Israel Medical Center

Baltimore VA Medical Center

Georgetown University

MUSC

UTHSC

Northwestern University

University of Alabama at Birmingham