drugset / Trial / NCT00005675
Oral Type I Collagen for Relieving Scleroderma
Phase 2
Completed
168 enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Baltimore VA Medical Center · collabBeth Israel Medical Center · collabGeorgetown University · collabJohns Hopkins University · collabMedical University of South Carolina · collabNorthwestern University · collabUTHSC · collabUniversity of Alabama at Birmingham · collabUniversity of California, Los Angeles · collabWayne State University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2000-04
- Primary completion
- 2005-05
- Completion
- —
Outcome
Missed primary endpoint
paper Although the results from this trial did not meet the primary outcome goals PMID 18512816 ↗
Publications
- Background Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z.
- Background 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. doi: 10.1002/art.20361. No abstract available.
- Postlethwaite AE, Wong WK, Clements P, Chatterjee S, Fessler BJ, Kang AH, Korn J, Mayes M, Merkel PA, Molitor JA, Moreland L, Rothfield N, Simms RW, Smith EA, Spiera R, Steen V, Warrington K, White B, Wigley F, Furst DE. A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum. 2008 Jun;58(6):1810-22. doi: 10.1002/art.23501.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bovine type I collagen | Protein / enzyme biologic | 500 ug | Oral |