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Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 00:31:36 GMT) PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 00:31:36 GMT) CTRI Number CTRI/2013/12/004264 [Registered on: 31/12/2013] - Trial Registered Retrospectively Last Modified On 10/12/2013 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study Oral glucocorticoids vs. intravenous glucocorticoids in managing thyroid associated orbitopathy Scientific Title of Monthly pulse methylprednisolone vs. oral prednisolone in treatment of thyroid ophthalmopathy: An Study open label randomized controlled trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Subhankar Chowdhury Trial Coordinator (multi-center study) Designation Professor and Head of the Department Affiliation IPGMER and SSKM Hospital Address Department of Endocrinology and Metabolism Room 8, 4th floor, Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Calcutta Kolkata WEST BENGAL 700020 India Phone 9831076501 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ajitesh Roy Query) Designation Post-doctoral trainee Affiliation IPGMER and SSKM Hospital Address Room 8, 4th floor, Ronald Ross Building Department of Endocrinology Institute of Post-Graduate Medical Education & Research (IPGMER) Kolkata-700020 Kolkata WEST BENGAL 700020 India Phone 9433135863 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Deep Dutta Designation MD (Medicine), DM (Endocrinology) Affiliation IPGMER and SSKM Hospital Address Room 9A, 4th floor, Ronald Ross Building Department of Endocrinology & Metabolism IPGMER and SSKM Hospital 244 AJC Bose Road Calcutta WEST BENGAL 700020 page 1 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in India Phone 9477406630 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Department of Endocrinology and Metabolism, IPGMER and SSKM Hospital, 244 AJC Bose Road, Kolkata-700020 Primary Sponsor Primary Sponsor Details Name Department of Endocrinology and Metabolism Address Room 6, 4th Floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road, Kolkata-700020 Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Deep Dutta Endocrinology Clinic Room-8, 4th Floor 9477406630 Ronald Ross Building Department of deepdutta2000@yahoo. Endocrinology and com Metabolism IPGMER and SSKM Hospital 244 AJC Bose Road, Kolkata-700020 Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 11/04/2011 No Committee IPGMER and SSKM Hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Patients of Graves’ disease with eye symptoms suggestive of Thyroid associated orbitopathy Intervention / Type Name Details Comparator Agent Comparator Agent Group-B Patients receiving oral Patients receiving oral prednisolone prednisolone (starting with 1mg/kg/day for 6 weeks then tapered gradually and stopped over 34-40 weeks, to reach a cumulative dose of prednisolone of 7.5 grams, e.g. in a 60 kg patient, 60mg/day for 6 weeks followed by tapering of 10mg 4 weekly till 20mg/day, then tapering by 5mg 4 weekly till 10 mg/day, then 7.5mg/day for 4 weeks, then 5mg/d till post page 2 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in synacthen 250mcg 1-hour cortisol18mcg/dl Intervention GROUP-A Patients receiving Patients receiving monthly iv. intravenous pulse methylprednisolone (0.5gm for 3 methylprednisolone consecutive days in a month for 4 months; total dose 6gm Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details Patients of moderately severe Thyroid associated orbitopathy (TAO) with moderate activity (Clinical activity score>2)were included.<br/> Moderate to severe TAO was defined as marked soft tissue swelling (2c by NOSPECS), and/or proptosis (?18mm in females; ?20mm in males; 3a or more by NOSPECS), and/or inconstant/constant diplopia in primary or reading position (4b by NOSPECS), and/or punctuate staining of cornea, without any optic nerve involvement, as suggested by European Group on Graves’ Orbitopathy Exclusion Criteria Exclusion Criteria Details Patients with mild TAO, dysthyroid optic neuropathy (DON) and severe sight-threatening TAO were excluded.Patients were excluded who had received steroids, radiotherapy, immunosuppressive therapy or surgery for TAO. Patients with comorbidities making glucocorticoid administration difficult (uncontrolled hypertension, uncontrolled diabetes, tuberculosis, immune-compromised state, chronic liver disease, viral hepatitis, tuberculosis) were excluded. Method of Generating Computer generated randomization Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Treatment outcomes will be assessed in terms of Patients will be followed up 3 monthly for the major response criteria (MRC) and Minor duration of study Response Criteria (MiRC. MRC include decrease in CAS score by ?3 points or improvement in diplopia. MiRC include decrease in lid retraction by ?2mm, decrease in proptosis by 2mm, decrease in CAS score by ?2 points or improvement in grade of soft tissue swelling. Responders (R) were defined as improvement in ?1 major criteria or ?2 minor criteria. Secondary Outcome Outcome Timepoints NIL NIL Target Sample Size Total Sample Size=50 Sample Size from India=50 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 02/05/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 page 3 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details NIL Brief Summary Introduction: Thyroid associated opthalmopathy (TAO) is the most common extrathyroidal manifestation of Graves’ disease is a disfiguring disorder physically mentally, emotionally and significantly impairing the quality of life.. Steroids, immunosuppressive therapy, radiation all have been tried in the treatment of TAO. However steroids form the mainstay of therapy in patients with moderately severe TAO. (1) Glucocorticoids are believed to act by inhibition of leucocyte chemotaxis and cytokine release, reduction in glycosaminoglycan synthesis by orbital fibroblasts, and down regulation of adhesion molecules (2) Glucocorticoids have been found to be most effective in patients with active opthalmopathy, with significant inflammatory features, with significant dysmotility especially diplopia in primary gaze and in whom vision is threatened. (3) Among the various available routes for administration of steroids, topical steroid drops have no role in managing TAO. Subconjunctival and retro-orbital steroid administration is not justified as neither they are more efficacious than oral or intravenous steroids nor do they protect from systemic side effects of steroids. Oral and intravenous steroids both have been commonly used in the treatment of TAO and have their advantages and disadvantages. (4-9) Two recent randomized controlled trials (RCT) have shown that pulse intravenous steroids have a higher rate of favorable response (88% vs. 63% and 77% vs. 51% respectively) with fewer side effects than oral steroids. (14,15) It has been suggested that clinical response can be seen as early as 1-2 weeks following initiation of intravenous steroids. (14,15) However hepatic failure is a rare complication of high dose intravenous steroids (seen at cumulative doses of methylprednisolone > 8gm and should be avoided). In another randomized trial, intravenous methylprednisolone (four cycles at 500 mg for 3 consecutive days at 4-week intervals) was found to be effective in treating inflammatory changes and ocular movements in 83% of patients as compared to 11% in those who received placebo. (11) Another regimen that has been tried consists of 12 weekly infusions of methylprednisolone with a cumulative dose of 4.5 g (500 mg weekly for 6 weeks, then 250 mg weekly for 6 weeks). (12) Optimal regimen for intravenous steroid therapy in TAO has not yet been established. Also on closely analyzing the data, it can be seen that monthly intravenous pulse methylprednisolone was found to be only marginally better than oral prednisolone (88% vs. 63%; P~0.02) (14) In fact in the same study, on patient self assessment, there was no significant difference in the response between intravenous vs. oral steroids (p=0.27) (14) It must be noted that the dose of oral steroid used while comparing intravenous vs. oral steroid regimens in TAO, was quite high, starting with 100mg/day (14,15). It is a well known fact that higher the dose, more the side effects. The standard immunosuppressive page 4 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
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