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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00001614 |
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Date of registration:
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03/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
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Scientific title:
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The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis |
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Date of first enrolment:
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July 1997 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001614 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Must meet American College of Rheumatology Criteria for JRA.
Must have active anterior uveitis defined as the presence of inflammatory cells in the
anterior chamber in at least one eye, or the current use of topical corticosteroids.
Must be between 2 and 18 years of age, inclusive.
Must have had previous therapy for uveitis.
Must be able to undergo a slit lamp biomicroscopy for assessment of anterior chamber
cells.
Must not have a media opacity that precludes assessment of anterior chamber inflammation.
Must not have received a periocular injection of corticosteroids within 2 months of
baseline.
Must not be currently receiving DMARD (disease modifying anti-rheumatic) therapy, with the
exception of prednisone at a dose no greater than 1.5-2.0 mg/kg/day, or methotrexate at a
dose no greater than 10 mg/m(2)/week.
Must not have active eye or joint inflammation requiring immediate addition or increase in
systemic anti-inflammatory medications.
Must not have involvement in prior clinical trials of type II collagen.
Must not have exposure within the past year to shark or other collagen preparations found
in health food stores.
Must not have a history of gastrointestinal disease which could affect the presentation of
type II collagen.
Women must not be pregnant or lactating.
Patients currently using Latanoprost, patients who have used Latanoprost within the last 2
weeks, or patients who are likely to need Latanoprost during the course of the study will
be excluded.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Uveitis
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Arthritis, Juvenile Rheumatoid
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Intervention(s)
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Drug: Chicken type II collagen
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Secondary ID(s)
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97-EI-0146
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970146
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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