Short-term Prednisone to Treat STA Study(SPTSS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Xinqiao Hospital of Chongqing
Sponsor:
Information provided by (Responsible Party):
Lian Duan, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier:
NCT01837433
First received: April 6, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Subacute Thyroiditis
Drug: Prednisone 1 week
Drug: Prednisone 6 weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis

Resource links provided by NLM:


Further study details as provided by Xinqiao Hospital of Chongqing:

Primary Outcome Measures:
  • The Efficiency of experimental group comparing with control group during 14 days [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.

  • hypothyroidism [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.

  • Adrenal insufficiency after withdraw in experimental group and control group. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    We will measure Lipids before and after withdraw prednisone in experimental and control group.


Other Outcome Measures:
  • Other side effects of prednisone [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    Such as,cushing appearance; female hirsutism, menstrual disorders, impotence in men; gastrointestinal ulcers; psychiatric symptoms: anxiety, agitation, fatigue


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Glucocorticoid
Active Comparator: Prednisone 6 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.
Drug: Prednisone 6 weeks
Guidelines recommend
Other Name: Glucocorticoid

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837433

Contacts
Contact: Lian Duan, Master +86 13637936332 jasonduan2011@gmail.com

Locations
China, Chongqing
The Second Affiliated Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400037
Contact: Lian Duan, Master    +86 13637936332    jasonduan2011@gmail.com   
Principal Investigator: Hongting Zheng, Ph D         
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
Investigators
Principal Investigator: Hongting Zheng, Ph.D Department of Endocrinology, The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
  More Information

No publications provided

Responsible Party: Lian Duan, Clinical Doctor, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT01837433     History of Changes
Other Study ID Numbers: XinqiaoH-001
Study First Received: April 6, 2013
Last Updated: May 26, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xinqiao Hospital of Chongqing:
Efficacy
safety
short
term
subacute thyroiditis

Additional relevant MeSH terms:
Prednisone
Thyroiditis
Thyroiditis, Subacute
Thyroid Diseases
Endocrine System Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014