Home » Trials » SLCTR/2012/002
A study to compare the effects of a new generic product of methimazole with a standard generic product of carbimazole on biochemical parameters in Graves' hyperthyroidism
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SLCTR Registration Number
SLCTR/2012/002
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A study to compare the effects of a new generic product of methimazole with a standard generic product of carbimazole on biochemical parameters in Graves' hyperthyroidism
Public Title of Trial
Carbimazole methimazole study
Disease or Health Condition(s) Studied
Graves' thyrotoxicosis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-10-129 (Ethical Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
To establish non-inferiority between a new generic product of methimazole with an approved product of carbimazole in Graves' hyperthyroidism ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Randomized controlled prospective clinical trial conducted at the medical clinics of the University Medical Unit, National Hospital of Sri Lanka, Diabetes Research Unit and private sector medical consultations. 60 consecutive newly diagnosed patients with Graves' thyrotoxicosis are recruited from the above mentioned clinics. They are randomized to study and control groups. The study group will be started on 20mg methimazole daily and the control group will be started on 30 mg carbimazole daily. Patients will be followed up at 4, 8 and 12 weeks with thyroid function tests. Doses are titrated according to the biochemical response. The study will be continued for 12 weeks
Inclusion criteria
All males and females with newly diagnosed Graves' thyrotoxicosis attending to the clinics mentioned above who are in the 18-70yrs age group Criteria for diagnosis of Graves' disease - Signs and symptoms of Graves' hyperthyroidism; Diffusely enlarged goiter; Elevated thyroid hormones; Free T4 - Suppressed TSH levels enlarged goiter
Exclusion criteria
Primary outcome(s)
|
1.
Normalization of free T4 |
[ End of 4 weeks of treatment ] |
Secondary outcome(s)
|
1.
Normalization of serum TSH and FT3, rate of response of the drugs, reduction of the FT4 by a unit measurement of the drug |
[ At 4, 8 and 12 weeks after starting treatment ] |
Target number/sample size
60
Countries of recruitment
Sri Lanka
Anticipated start date
2012-03-01
Anticipated end date
2013-01-31
Date of first enrollment
2012-05-06
Date of study completion
Recruitment status
Terminated
Funding source
MSJ industries (Ceylon) (Pvt/ltd)
Regulatory approvals
Status
Approved
Date of Approval
2011-08-08
Approval number
EC-10-129
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Dinithi Fernando
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo
0112695300-203
dinithianush@gmail.com
Contact Person for Public Queries
Dr. Dinithi Fernando
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo
0112695300-203
dinithianush@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
