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Short-term Prednisone to Treat STA Study(SPTSS) (STA)

Primary Purpose

Subacute Thyroiditis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Prednisone 1 week
Prednisone 6 weeks
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacute Thyroiditis focused on measuring Efficacy, safety, short, term, subacute thyroiditis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prednisone 1 week

Prednisone 6 weeks

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

recurrence rate
The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.
hypothyroidism
change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.
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.
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.
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.
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.
Change of Lipids in experimental and control group during medication.
We will measure Lipids before and after withdraw prednisone in experimental and control group.

Full Information

First Posted
April 6, 2013
Last Updated
May 18, 2015
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT01837433
Brief Title
Short-term Prednisone to Treat STA Study(SPTSS)
Acronym
STA
Official Title
Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Thyroiditis
Keywords
Efficacy, safety, short, term, subacute thyroiditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone 1 week
Arm Type
Experimental
Arm Description
Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.
Arm Title
Prednisone 6 weeks
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone 1 week
Other Intervention Name(s)
Glucocorticoid
Intervention Description
Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Prednisone 6 weeks
Other Intervention Name(s)
Glucocorticoid
Intervention Description
Guidelines recommend
Primary Outcome Measure Information:
Title
The Efficiency of experimental group comparing with control group during 14 days
Description
We will observe change of erythrocyte sedimentation rate from >20mm/h to normal,C-reactive protein,pain and goiter disappear after 14 days.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
recurrence rate
Description
The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.
Time Frame
180 days
Title
hypothyroidism
Description
change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.
Time Frame
180 days
Title
Adrenal insufficiency after withdraw in experimental group and control group.
Description
The Symptom such as anorexia, nausea, vomiting, abdominal pain, fatigue, weakness, collapse, muscle pain, joint pain, weight loss, orthostatic hypotension, lethargy and depression.
Time Frame
42 days
Title
Change of blood glucose in experimental group and control group.
Description
Glucose change when taking medicine:from normal blood glucose on baseline to hyperglycemia at the special time during medication.
Time Frame
42 days
Title
Change of blood pressure in experimental and control group during medication.
Description
We will measure blood pressure before and after withdraw prednisone in experimental and control group.
Time Frame
42 days
Title
Bone metabolism after withdraw in experimental group and control group.
Description
We will measure Bone metabolism markers before and after withdraw prednisone in experimental and control group.
Time Frame
42 days
Title
Change of Lipids in experimental and control group during medication.
Description
We will measure Lipids before and after withdraw prednisone in experimental and control group.
Time Frame
42 days
Other Pre-specified Outcome Measures:
Title
Other side effects of prednisone
Description
Such as,cushing appearance; female hirsutism, menstrual disorders, impotence in men; gastrointestinal ulcers; psychiatric symptoms: anxiety, agitation, fatigue
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongting Zheng, Ph.D
Organizational Affiliation
Department of Endocrinology, The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China

12. IPD Sharing Statement

Citations:
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23227861
Citation
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Short-term Prednisone to Treat STA Study(SPTSS)

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