NCT06285617

Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis

Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis: An Open-label, Randomized, Controlled, and Multicenter Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 mg/day 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 mg/week 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.

Conditions

• Subacute Thyroiditis

Interventions

Type	Name	Description
DRUG	1-week predisone+1-week celecoxib	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 (a type of nonsteroidal anti-inflammatory drug) on day 1 and 200 mg twice daily for the remaining 6 days until celecoxib withdrawal.
DRUG	6-weeks predisone	20 and 10 mg prednisone in the morning and afternoon, respectively, daily in the first week, and then reduced by 5 mg/week from the second week until withdrawal in the sixth week.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-01-31
• Completion: 2025-04-30
• First posted: 2024-02-29
• Last updated: 2024-02-29