Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285617
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-01-24
Brief Title:
Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis
Sponsor:
Xinqiao Hospital of Chongqing
Organization:
Xinqiao Hospital of Chongqing
Study Overview
Official Title:
Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis An Open-label Randomized Controlled and Multicenter Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAT
Brief Summary:
The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis The main questions it aims to answer are Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mgday prednisone for 1 week followed by 1 week of nonsteroidal anti-inflammatory drugs or the conventional 6-week prednisone therapy in the control group
Detailed Description:
This is an open-label randomized controlled and multicenter trial Patients with moderate-to-severe symptoms were randomly assigned to receive either 20 and 10 mg prednisone in the morning and afternoon respectively daily for 1 week in the second week these participants received 400 mg celecoxib on day 1 and 200 mg twice daily for the remaining 6 days until celecoxib withdrawal or 20 and 10 mg prednisone in the morning and afternoon respectively daily in the first week and then reduced by 5 mgweek from the second week until withdrawal in the sixth week The primary endpoint was intergroup differences in treatment efficacy at the end of the treatment course Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6 12 and 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None