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

NCT ID: NCT06285617

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-04-30

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 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

Keywords

Short-Term Prednisone; Subacute Thyroiditis; Open-label, Randomized, Controlled, and Multicenter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Participants in the experimental group received 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.

Group Type: EXPERIMENTAL

1-week predisone+1-week celecoxib

Intervention Type: DRUG

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.

Control group

Participants in the control group received 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.

Group Type: ACTIVE_COMPARATOR

6-weeks predisone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

No available; No available

Eligibility Criteria

Inclusion Criteria

• We enrolled adult patients (age 18-70) with Subacute Thyroiditis (SAT) scores ≥3 points. SAT was diagnosed on the basis of diagnostic criteria. The severity of SAT was scored as follows: fever - none, <38℃, and >38℃ (0, 1, and 2 points, respectively); tenderness - none, mild, and severe (0, 1, and 2 points, respectively); goiter by ultrasonography or palpation - none and yes (0 and 1 point, respectively); and ESR - normal, 25-60 mm/h, and >60 mm/h (0, 1, and 2 points, respectively).

Exclusion Criteria

• Patients who were diagnosed with diabetes, an active peptic ulcer, benign and malignant tumors, hepatic dysfunction, recurrent SAT, and already on glucocorticoid therapy were excluded within 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Lian Duan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Duan L, Feng X, Zhang R, Tan X, Xiang X, Shen R, Zheng H. Short-Term Versus 6-Week Prednisone In The Treatment Of Subacute Thyroiditis: A Randomized Controlled Trial. Endocr Pract. 2020 Aug;26(8):900-908. doi: 10.4158/EP-2020-0096.

Reference Type: BACKGROUND

PMID: 33471681 (View on PubMed)

Alves C, Robazzi TC, Mendonca M. Withdrawal from glucocorticosteroid therapy: clinical practice recommendations. J Pediatr (Rio J). 2008 May-Jun;84(3):192-202. doi: 10.2223/JPED.1773.

Reference Type: BACKGROUND

PMID: 18535733 (View on PubMed)

Benbassat CA, Olchovsky D, Tsvetov G, Shimon I. Subacute thyroiditis: clinical characteristics and treatment outcome in fifty-six consecutive patients diagnosed between 1999 and 2005. J Endocrinol Invest. 2007 Sep;30(8):631-5. doi: 10.1007/BF03347442.

Reference Type: BACKGROUND

PMID: 17923793 (View on PubMed)

Kubota S, Nishihara E, Kudo T, Ito M, Amino N, Miyauchi A. Initial treatment with 15 mg of prednisolone daily is sufficient for most patients with subacute thyroiditis in Japan. Thyroid. 2013 Mar;23(3):269-72. doi: 10.1089/thy.2012.0459.

Reference Type: BACKGROUND

PMID: 23227861 (View on PubMed)

Waljee AK, Rogers MA, Lin P, Singal AG, Stein JD, Marks RM, Ayanian JZ, Nallamothu BK. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. BMJ. 2017 Apr 12;357:j1415. doi: 10.1136/bmj.j1415.

Reference Type: BACKGROUND

PMID: 28404617 (View on PubMed)

Broersen LH, Pereira AM, Jorgensen JO, Dekkers OM. Adrenal Insufficiency in Corticosteroids Use: Systematic Review and Meta-Analysis. J Clin Endocrinol Metab. 2015 Jun;100(6):2171-80. doi: 10.1210/jc.2015-1218. Epub 2015 Apr 6.

Reference Type: BACKGROUND

PMID: 25844620 (View on PubMed)

Oray M, Abu Samra K, Ebrahimiadib N, Meese H, Foster CS. Long-term side effects of glucocorticoids. Expert Opin Drug Saf. 2016;15(4):457-65. doi: 10.1517/14740338.2016.1140743. Epub 2016 Feb 6.

Reference Type: BACKGROUND

PMID: 26789102 (View on PubMed)

Pearce EN, Farwell AP, Braverman LE. Thyroiditis. N Engl J Med. 2003 Jun 26;348(26):2646-55. doi: 10.1056/NEJMra021194. No abstract available.

Reference Type: BACKGROUND

PMID: 12826640 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/33471681/

This is the published small sample, single center, randomized controlled studies. Short-Term Versus 6-Week Prednisone In The Treatment Of Subacute Thyroiditis: A Randomized Controlled Trial

Other Identifiers

2022GDRC016

Identifier Type: -

Identifier Source: org_study_id