Short-term Prednisone to Treat STA Study(SPTSS)

Subacute Thyroiditis Clinical Trial

— STA  

Official title:

Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837433
• Other study ID #: XinqiaoH-001
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2013
• Last updated: May 18, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis

The investigators hypothesize that less adverse reactions will be observed, comparing with the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent hypothyroidism aren't significant difference.

Description:

Comparing with the guidelines recommend, short-term (one week)prednisone and nsaids following up next week to treat moderate and severe subacute thyroiditis will be assessed.

The patients in wards will be assessed from temperature,erythrocyte sedimentation rate,C-reactive protein,local pain and goiter.The random treatment will be executed in moderate and severe SAT after informed consent be signed.

Subjects will be monitored once every 2 weeks.If patients complained of pain in their neck or if the erythrocyte sedimentation rate is still high,after discontinuation of prednisone, prednisone treatment will be resumed in moderate and severe subject and non-steroidal anti-inflammatory drugs will be used in mild subject.Anti-ulcer drugs will be administered to all patients.

The endpoint of the study are efficiency and safety of short-term prednisone treating. The investigators will assess adrenal insufficiency (such as anorexia, nausea, vomiting, abdominal pain),steroid withdrawal syndrome, recurrence rate and hypothyroidism. The investigators will observe erythrocyte sedimentation rate,pain,steroid level and thyroid function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years patients with Moderate and severe subacute thyroiditis

Exclusion Criteria:

• adrenal cortical dysfunction,

• use of corticosteroids in nearly three months,

• mild subacute thyroiditis,

• non-onset STA,

• family history of diabetes,

• gastric ulcer,

• the special medication history,

• heart,liver and renal insufficiency,

• tumors,

• tuberculosis and

• poor compliance.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subacute Thyroiditis
• Thyroiditis

Intervention

Drug:
• Prednisone 1 week
Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.
• Prednisone 6 weeks
Guidelines recommend

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (17)

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

Bahn Chair RS, Burch HB, Cooper DS, Garber JR, Greenlee MC, Klein I, Laurberg P, McDougall IR, Montori VM, Rivkees SA, Ross DS, Sosa JA, Stan MN; American Thyroid Association; American Association of Clinical Endocrinologists. Hyperthyroidism and other ca — View Citation

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. — View Citation

Carella MJ, Srivastava LS, Gossain VV, Rovner DR. Hypothalamic-pituitary-adrenal function one week after a short burst of steroid therapy. J Clin Endocrinol Metab. 1993 May;76(5):1188-91. — View Citation

Desailloud R, Hober D. Viruses and thyroiditis: an update. Virol J. 2009 Jan 12;6:5. doi: 10.1186/1743-422X-6-5. Review. — View Citation

Fatourechi V, Aniszewski JP, Fatourechi GZ, Atkinson EJ, Jacobsen SJ. Clinical features and outcome of subacute thyroiditis in an incidence cohort: Olmsted County, Minnesota, study. J Clin Endocrinol Metab. 2003 May;88(5):2100-5. — View Citation

Henzen C, Suter A, Lerch E, Urbinelli R, Schorno XH, Briner VA. Suppression and recovery of adrenal response after short-term, high-dose glucocorticoid treatment. Lancet. 2000 Feb 12;355(9203):542-5. — View Citation

Iitaka M, Momotani N, Ishii J, Ito K. Incidence of subacute thyroiditis recurrences after a prolonged latency: 24-year survey. J Clin Endocrinol Metab. 1996 Feb;81(2):466-9. — View Citation

Krasner AS. Glucocorticoid-induced adrenal insufficiency. JAMA. 1999 Aug 18;282(7):671-6. — View Citation

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. — View Citation

Longui CA. Glucocorticoid therapy: minimizing side effects. J Pediatr (Rio J). 2007 Nov;83(5 Suppl):S163-77. Epub 2007 Nov 14. Review. — View Citation

Mizukoshi T, Noguchi S, Murakami T, Futata T, Yamashita H. Evaluation of recurrence in 36 subacute thyroiditis patients managed with prednisolone. Intern Med. 2001 Apr;40(4):292-5. — View Citation

Nishihara E, Amino N, Ohye H, Ota H, Ito M, Kubota S, Fukata S, Miyauchi A. Extent of hypoechogenic area in the thyroid is related with thyroid dysfunction after subacute thyroiditis. J Endocrinol Invest. 2009 Jan;32(1):33-6. — View Citation

Nishihara E, Ohye H, Amino N, Takata K, Arishima T, Kudo T, Ito M, Kubota S, Fukata S, Miyauchi A. Clinical characteristics of 852 patients with subacute thyroiditis before treatment. Intern Med. 2008;47(8):725-9. Epub 2008 Apr 16. — View Citation

Pearce EN, Farwell AP, Braverman LE. Thyroiditis. N Engl J Med. 2003 Jun 26;348(26):2646-55. Review. Erratum in: N Engl J Med. 2003 Aug 7;349(6):620. — View Citation

Vagenakis AG, Abreau CM, Braverman LE. Prevention of recurrence in acute thyoiditis following corticosteroid withdrawal. J Clin Endocrinol Metab. 1970 Dec;31(6):705-8. — View Citation

Volpé R. The management of subacute (DeQuervain's) thyroiditis. Thyroid. 1993 Fall;3(3):253-5. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other side effects of prednisone	Such as,cushing appearance; female hirsutism, menstrual disorders, impotence in men; gastrointestinal ulcers; psychiatric symptoms: anxiety, agitation, fatigue	42 days	Yes
Primary	The Efficiency of experimental group comparing with control group during 14 days	We will observe change of erythrocyte sedimentation rate from >20mm/h to normal,C-reactive protein,pain and goiter disappear after 14 days.	14 days	No
Secondary	recurrence rate	The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.	180 days	No
Secondary	hypothyroidism	change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.	180 days	No
Secondary	Adrenal insufficiency after withdraw in experimental group and control group.	The Symptom such as anorexia, nausea, vomiting, abdominal pain, fatigue, weakness, collapse, muscle pain, joint pain, weight loss, orthostatic hypotension, lethargy and depression.	42 days	Yes
Secondary	Change of blood glucose in experimental group and control group.	Glucose change when taking medicine:from normal blood glucose on baseline to hyperglycemia at the special time during medication.	42 days	Yes
Secondary	Change of blood pressure in experimental and control group during medication.	We will measure blood pressure before and after withdraw prednisone in experimental and control group.	42 days	Yes
Secondary	Bone metabolism after withdraw in experimental group and control group.	We will measure Bone metabolism markers before and after withdraw prednisone in experimental and control group.	42 days	Yes
Secondary	Change of Lipids in experimental and control group during medication.	We will measure Lipids before and after withdraw prednisone in experimental and control group.	42 days	Yes