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Completed

NCT Number: NCT01837433

Short-term Prednisone to Treat STA Study(SPTSS)

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone 1 week

Drug

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

Other names: Glucocorticoid

Prednisone 6 weeks

Drug

Guidelines recommend

Other names: Glucocorticoid

Primary outcomes

  1. The Efficiency of experimental group comparing with control group during 14 days

    Time frame: 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.

Secondary outcomes

  1. recurrence rate

    Time frame: 180 days

    The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.

  2. hypothyroidism

    Time frame: 180 days

    change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.

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

    Time frame: 42 days

    The Symptom such as anorexia, nausea, vomiting, abdominal pain, fatigue, weakness, collapse, muscle pain, joint pain, weight loss, orthostatic hypotension, lethargy and depression.

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

    Time frame: 42 days

    Glucose change when taking medicine:from normal blood glucose on baseline to hyperglycemia at the special time during medication.

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

    Time frame: 42 days

    We will measure blood pressure before and after withdraw prednisone in experimental and control group.

  6. Bone metabolism after withdraw in experimental group and control group.

    Time frame: 42 days

    We will measure Bone metabolism markers before and after withdraw prednisone in experimental and control group.

  7. Change of Lipids in experimental and control group during medication.

    Time frame: 42 days

    We will measure Lipids before and after withdraw prednisone in experimental and control group.

Other outcomes

  1. Other side effects of prednisone

    Time frame: 42 days

    Such as,cushing appearance; female hirsutism, menstrual disorders, impotence in men; gastrointestinal ulcers; psychiatric symptoms: anxiety, agitation, fatigue

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

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

Acronym: STA

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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