NCT01837433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

April 6, 2013

Last Update Submit

May 18, 2015

Conditions

Subacute Thyroiditis

Keywords

Efficacysafetyshorttermsubacute thyroiditis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • recurrence rate

    180 days

  • hypothyroidism

    180 days

  • Adrenal insufficiency after withdraw in experimental group and control group.

    42 days

  • Change of blood glucose in experimental group and control group.

    42 days

  • Change of blood pressure in experimental and control group during medication.

    42 days

  • +2 more secondary outcomes

Other Outcomes (1)

  • Other side effects of prednisone

    42 days

Study Arms (2)

Prednisone 1 week

EXPERIMENTAL

Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.

Drug: Prednisone 1 week

Prednisone 6 weeks

ACTIVE COMPARATOR

Oral 30 mg/day of prednisone will be administered as the initial dose for the treatment of SAT in first week,then tapered by 5mg every 1 week,the duration of prednisone will be 6 weeks.

Drug: Prednisone 6 weeks

Interventions

Prednisone 1 weekDRUG

Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.

Also known as: Glucocorticoid
Prednisone 1 week
Prednisone 6 weeksDRUG

Guidelines recommend

Also known as: Glucocorticoid
Prednisone 6 weeks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years patients with Moderate and severe subacute thyroiditis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Related Publications (17)

  • 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: 23227861RESULT

  • 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. doi: 10.1210/jc.2002-021799.

    PMID: 12727961RESULT

  • 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. doi: 10.2169/internalmedicine.47.0740. Epub 2008 Apr 16.

    PMID: 18421188RESULT

  • 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 causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011 Jun;21(6):593-646. doi: 10.1089/thy.2010.0417. Epub 2011 Apr 21.

    PMID: 21510801RESULT

  • 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. doi: 10.1007/BF03345675.

    PMID: 19337012RESULT

  • 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. doi: 10.1210/jcem.81.2.8636251.

    PMID: 8636251RESULT

  • 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. doi: 10.1210/jcem-31-6-705. No abstract available.

    PMID: 4098399RESULT

  • Volpe R. The management of subacute (DeQuervain's) thyroiditis. Thyroid. 1993 Fall;3(3):253-5. doi: 10.1089/thy.1993.3.253.

    PMID: 8257868RESULT

  • 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: 12826640RESULT

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

    PMID: 19138419RESULT

  • 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. doi: 10.2169/internalmedicine.40.292.

    PMID: 11334386RESULT

  • 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: 17923793RESULT

  • 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. doi: 10.1210/jcem.76.5.8388401.

    PMID: 8388401RESULT

  • 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: 18535733RESULT

  • Krasner AS. Glucocorticoid-induced adrenal insufficiency. JAMA. 1999 Aug 18;282(7):671-6. doi: 10.1001/jama.282.7.671. No abstract available.

    PMID: 10517721RESULT

  • 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. doi: 10.1016/S0140-6736(99)06290-X.

    PMID: 10683005RESULT

  • Longui CA. Glucocorticoid therapy: minimizing side effects. J Pediatr (Rio J). 2007 Nov;83(5 Suppl):S163-77. doi: 10.2223/JPED.1713. Epub 2007 Nov 14.

    PMID: 18000630RESULT

MeSH Terms

Conditions

Thyroiditis, Subacute

Interventions

PrednisoneGlucocorticoids

Condition Hierarchy (Ancestors)

ThyroiditisThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Hongting Zheng, Ph.D

    Department of Endocrinology, The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Doctor

Study Record Dates

First Submitted

April 6, 2013

First Posted

April 23, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)