Status:
UNKNOWN
Efficacy and Safety of Cholestyramine and Prednisolone as Adjunctive Therapy in Treatment of Overt Hyperthyroidism
Lead Sponsor:
Clinical Research Centre, Malaysia
Collaborating Sponsors:
Ministry of Health, Malaysia
Conditions:
Hyperthyroidism
Graves Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Hyperthyroidism is the second most common endocrine disorder in the world with Graves' disease being the commonest. Anti thyroid drugs including methimazole, carbimazole, and propylthiouracil are effe...
Detailed Description
Hyperthyroidism is the second most common endocrine disorder in the world with an estimate prevalence rate of 0.5-1.3% with Graves' disease being the commonest cause. Uncontrolled hyperthyroidism res...
Eligibility Criteria
Inclusion
- Provision of written consent by subject or guardian.
- Subject of either sex, more than 18 years of age
- Subjects with moderate to severe overt hyperthyroidism (caused by Graves' disease).
- Moderate to severe overt hyperthyroidism is defined as Free T4\> 1.5 times upper limit of normal reference range and TSH below lower limit of reference range, who are either newly diagnosed or previously diagnosed and receiving ATDs currently.
- Graves disease is defined as hyperthyroidism coupled with clinical signs of symmetrical diffuse goiter, thyroid orbitopathy, or diffuse and vascular thyroid on ultrasound or positive TRAb antibody
- Female patients will either be
- post-menopausal for \> 2 years
- Women of childbearing potential can be included if surgically sterile or using double contraception with at least one method being barrier contraception. Women of childbearing potential must have a negative pregnancy test at screening and at randomisation. Pregnancy tests will be repeated during each visit.
Exclusion
- Inability or unwillingness to provide written consent.
- Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- Pregnancy, breastfeeding or use of non-reliable method of contraception.
- Subjects with history of chronic liver disease, chronic renal failure, heart failure, diabetes mellitus
- Subjects with history of peptic ulcer disease, upper gastrointestinal bleeding, diverticulitis or ulcerative colitis.
- Subjects who have recently had live or attenuated virus vaccines
- Subjects with current infection (systemic fungal, active tuberculosis, cerebral malaria, viral hepatitis, HIV)
- Subjects with cataracts and glaucoma
- Subjects with osteoporosis
- Subjects with psychiatric disorders
- Subjects with complete biliary obstruction, bleeding disorders, hypertriglyceridemia (fasting triglyceride levels \> 300mg/dL)
- Previous history of adverse reactions to cholestyramine or other bile acid sequestrants
- Previous history of adverse reactions to prednisolone or other steroid compound
- Current use of cholestyramine or prednisolone or other steroid compound
- Participation in another clinical trial and/or receipt of cholestyramine or prednisolone within 4 weeks prior to screening visit.
- Subjects with history of bronchial asthma, bronchospasm, peripheral vascular disease or adverse reactions to propanolol
- Subjects with adverse reactions to carbimazole
- Hypokalemia (serum K+ \<3.5 mmol/L)
- Thyroid storm defined as Burch Wartofsky Score \>45
Key Trial Info
Start Date :
May 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03303053
Start Date
May 11 2017
End Date
March 1 2018
Last Update
October 5 2017
Active Locations (3)
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1
Hospital Putrajaya
Putrajaya, Kuala Lumpur, Malaysia, 62250
2
Hospital Queen Elizabeth 2
Kota Kinabalu, Sabah, Malaysia, 88300
3
Hospital Ampang
Ampang, Selangor, Malaysia, 68000