Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005675
Status:
COMPLETED
Last Update Posted:
2010-05-25
First Post:
2000-05-26
Brief Title:
Oral Type I Collagen for Relieving Scleroderma
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-048 | None | None | None |