CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
Oral bovine type I collagen +1 moredrug
Likely dose
Oral bovine type I collagen 500 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00005675
NCT00005675Phase 2Completed
CompareCT.gov

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

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·interventional·Posted May 29, 2000·Updated May 25, 2010

In Brief

A Phase 2 clinical trial evaluating Oral bovine type I collagen and Placebo for Scleroderma and Connective Tissue Diseases. Completed, enrolled 168 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Connective Tissue Diseases
CountriesUnited States
CollaboratorsWayne State University, University of California, Los Angeles, UTHSC, Medical University of South Carolina, Beth Israel Medical Center, University of Alabama at Birmingham, Johns Hopkins University, Georgetown University, Baltimore VA Medical Center, Northwestern University

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2000
Enrollment StartApr 1, 2000
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 26.1 years ago

Interventions

Oral bovine type I collagendrug

500 mcg of CI daily for 15 months

Placebodrug

CI placebo daily for 15 months