Subacute ThyroiditisPhase 4STANCT01837433
Short-term Prednisone to Treat STA Study(SPTSS)
A Phase 4 study testing Prednisone 1 week and Prednisone 6 weeks in people with Subacute Thyroiditis, run by Xinqiao Hospital of Chongqing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subacute Thyroiditis
- What is being tested?
- Prednisone 1 week and Prednisone 6 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years patients with Moderate and severe subacute thyroiditis
Who cannot join
- adrenal cortical dysfunction,
- use of corticosteroids in nearly three months,
- mild subacute thyroiditis,
- non-onset STA,
- family history of diabetes,
- gastric ulcer,
Show all 11Show fewer
- the special medication history,
- heart，liver and renal insufficiency,
- tumors,
- tuberculosis and
- poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037
About this study
Official title: Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
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.
Read the 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.
- Conditions
- Subacute Thyroiditis
- Being tested
- Prednisone 1 week, Prednisone 6 weeks
- Keywords
- Efficacy, safety, short, term, subacute thyroiditis
- Medical subject headings
- Thyroiditis, Subacute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone 1 weekDrug
Also called Glucocorticoid
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 weeksDrug
Also called Glucocorticoid
Guidelines recommend
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Prednisone 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (7)
recurrence rate
The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.
Measured: 180 days
hypothyroidism
change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.
Measured: 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.
Measured: 42 days
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.
Measured: 42 days
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.
Measured: 42 days
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.
Measured: 42 days
Change of Lipids in experimental and control group during medication.
We will measure Lipids before and after withdraw prednisone in experimental and control group.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Subacute ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lian Duan, Xinqiao Hospital of Chongqing
- Investigators
- Hongting Zheng, Ph.D, Principal investigator, Department of Endocrinology, The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837433
- Sponsor's protocol ID
- XinqiaoH-001
- Acronym
- STA
- Status last verified
- May 2015
- First submitted
- 6 Apr 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23227861Fatourechi 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.
PubMed 12727961Nishihara 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.
PubMed 18421188Bahn 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.
PubMed 21510801Nishihara 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.
PubMed 19337012Iitaka 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.
PubMed 8636251Vagenakis 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.
PubMed 4098399Volpe R. The management of subacute (DeQuervain's) thyroiditis. Thyroid. 1993 Fall;3(3):253-5. doi: 10.1089/thy.1993.3.253.
PubMed 8257868Pearce EN, Farwell AP, Braverman LE. Thyroiditis. N Engl J Med. 2003 Jun 26;348(26):2646-55. doi: 10.1056/NEJMra021194. No abstract available.
PubMed 12826640Desailloud R, Hober D. Viruses and thyroiditis: an update. Virol J. 2009 Jan 12;6:5. doi: 10.1186/1743-422X-6-5.
PubMed 19138419Mizukoshi 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.
PubMed 11334386Benbassat 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.
PubMed 17923793Carella 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.
PubMed 8388401Alves 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.
PubMed 18535733Krasner AS. Glucocorticoid-induced adrenal insufficiency. JAMA. 1999 Aug 18;282(7):671-6. doi: 10.1001/jama.282.7.671. No abstract available.
PubMed 10517721
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
- ClinicalTrials.gov ID
- NCT01837433
- Acronym / sponsor ID
- STA / XinqiaoH-001
- Conditions
- Subacute Thyroiditis
- Keywords
- Efficacy, safety, short, term, subacute thyroiditis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone 1 week | Experimental | Drug: Prednisone 1 weekPrednisone 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 | Active comparator | Drug: Prednisone 6 weeksOral 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-70 years patients with Moderate and severe subacute thyroiditis
Key exclusion criteria (11 listed)
- adrenal cortical dysfunction,
- use of corticosteroids in nearly three months,
- mild subacute thyroiditis,
- non-onset STA,
- family history of diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone 1 weekAlso: GlucocorticoidPrednisone 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 weeksAlso: GlucocorticoidGuidelines recommend | Drug | Prednisone 6 weeks |
Primary outcome
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.
7 secondary outcomes
recurrence rate
Time frame: 180 days
hypothyroidism
Time frame: 180 days
Adrenal insufficiency after withdraw in experimental group and control group.
Time frame: 42 days
Change of blood glucose in experimental group and control group.
Time frame: 42 days
Change of blood pressure in experimental and control group during medication.
Time frame: 42 days
Bone metabolism after withdraw in experimental group and control group.
Time frame: 42 days
Change of Lipids in experimental and control group during medication.
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Results publication: PubMed 23227861Kubota 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.
- Results publication: PubMed 12727961Fatourechi 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.
- Results publication: PubMed 18421188Nishihara 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.
- Results publication: PubMed 21510801Bahn 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.
- Results publication: PubMed 19337012Nishihara 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.
- Results publication: PubMed 8636251Iitaka 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.
- Results publication: PubMed 4098399Vagenakis 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.
- Results publication: PubMed 8257868Volpe R. The management of subacute (DeQuervain's) thyroiditis. Thyroid. 1993 Fall;3(3):253-5. doi: 10.1089/thy.1993.3.253.
- Results publication: PubMed 12826640Pearce EN, Farwell AP, Braverman LE. Thyroiditis. N Engl J Med. 2003 Jun 26;348(26):2646-55. doi: 10.1056/NEJMra021194. No abstract available.
- Results publication: PubMed 19138419Desailloud R, Hober D. Viruses and thyroiditis: an update. Virol J. 2009 Jan 12;6:5. doi: 10.1186/1743-422X-6-5.
- Results publication: PubMed 11334386Mizukoshi 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.
- Results publication: PubMed 17923793Benbassat 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.
Related trials for Subacute Thyroiditis
RecruitingPhase 2/3
Colchicine for Autoimmune and Subacute Thyroiditis
Hashimoto Thyroiditis, Subacute Thyroiditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongting Zheng, Ph.D principal investigator
Department of Endocrinology, The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone 1 week and Prednisone 6 weeks in people with Subacute Thyroiditis, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficiency of experimental group comparing with control group during 14 days (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837433, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.