Trial | NCT00005675  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    collagen ...

  • Study Participants

    168
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.
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.
Study Started
Apr 30
2000
Primary Completion
May 31
2005
Last Update
May 25
2010
Estimate

Drug Oral bovine type I collagen

500 mcg of CI daily for 15 months

  • Other names: CI

Drug Placebo

CI placebo daily for 15 months

1 Experimental

Participants will receive oral bovine type I collagen (CI) daily for 15 months

2 Placebo Comparator

Participants will receive placebo daily for 15 months.

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
No Results Posted