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

NCT06285617 | Not Yet Recruiting Phase 3

• 1 other identifier: 2022GDRC016
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subacute Thyroiditis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The difference in efficacy between the two groups at the completion.

  Efficacy is defined as no pain in the thyroid region through palpation and pain assessment using visual analog scoring, and normalization of CRP level.

  The palpation and CRP will investigate at 2nd (experimental group) or 6th (control group) weeks.

Secondary Outcomes (6)

• Thyroid function

  Thyroid function will be measured at weeks 6, 12, and 24 after the initial treatment.

• Total cholesterol (TC)

  TC will be measured at 2nd (experimental group) or 6th (control group) weeks.

• Triglycerides (TG)

  TG will be measured at 2nd (experimental group) or 6th (control group) weeks.

• Systolic blood pressure (SBP)

  SBP will be measured at 2nd (experimental group) or 6th (control group) weeks.

• Diastolic blood pressure (DBP)

  DBP will be measured at 2nd (experimental group) or 6th (control group) weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: 1-week predisone+1-week celecoxib

Control group

ACTIVE COMPARATOR

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.

Drug: 6-weeks predisone

Interventions

1-week predisone+1-week celecoxib 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.

Also known as: No available

Experimental group

6-weeks predisone 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.

Also known as: No available

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Related Publications (8)

• 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.

  PMID: 33471681 BACKGROUND

• 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.

  PMID: 18535733 BACKGROUND

• 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.

  PMID: 17923793 BACKGROUND

• 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.

  PMID: 23227861 BACKGROUND

• 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.

  PMID: 28404617 BACKGROUND

• 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.

  PMID: 25844620 BACKGROUND

• 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.

  PMID: 26789102 BACKGROUND

• 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.

  PMID: 12826640 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Thyroiditis, Subacute

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Prednisone

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 29, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02