The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05964452
Recruitment Status : **RECRUITING NOW**
First Posted : July 28, 2023
Last Update Posted : July 28, 2023
Sponsor:
Information provided by (Responsible Party):
Dan Mihailescu, Cook County Health
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Brief Summary:
To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves’ disease.
Graves Disease
Drug: Methimazole Tablets
Detailed Description:
We aim to conduct a prospective observational study in 60 patients with newly diagnosed Graves’ disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm. The patient number is based on 90% power and projected efficacy of 70% patients reaching target.
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Study Type :
Observational
Estimated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Efficacy of Cook County Health’s Methimazole Dosing Algorithm in the Setting of ne Onset Graves’ Hyperthyroidism
Actual Study Start Date :
February 14, 2022
Estimated Primary Completion Date :
February 14, 2024
Estimated Study Completion Date :
February 14, 2024
Resource links provided by the National Library of Medicine
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Intervention Details:
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Primary Outcome Measures :
Achievement of euthyroid state [ Time Frame: 17 weeks ]
The proportion of patients achieving euthyroid state during the study period
Secondary Outcome Measures :
Factors influencing achievement of euthyroid state [ Time Frame: 17 weeks ]
Identifying variables that correlate with achievement of euthyroid state
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Information from the National Library of Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Sampling Method:
Non-Probability Sample
Adults with new onset Graves’ disease.
Inclusion Criteria:
Non-pregnant adults (>18 years of age) with new diagnosis of Graves’ Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and
either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm.
Exclusion Criteria:
Pregnant patients
hyperthyroidism due to other causes, example – Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc.
Graves patients who present with atrial fibrillation, CHF or other end organ damage
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964452
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Cook County Health
Chicago, Illinois, United States, 60612
Contact: Dan Mihailescu, MD 312-864-0531 dan.mihailescu@cookcountyhhs.org
Cook County Health
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Principal Investigator:
Dan Mihailescu, MD
Cook County Health
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Responsible Party:
Dan Mihailescu, MD Endocrinology Cluster Director, Cook County Health
ClinicalTrials.gov Identifier:
NCT05964452
Other Study ID Numbers:
22-010
First Posted:
July 28, 2023 Key Record Dates
Last Update Posted:
July 28, 2023
Last Verified:
July 2023
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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Graves DiseaseExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidism
Autoimmune DiseasesImmune System DiseasesMethimazoleAntithyroid AgentsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of Drugs
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
