Clinical trial • Endocrinology
Aqueous Iodine Solution 5% for Hyperthyroidism|Graves' disease|Toxic nodular goiter
Clinical trial of Aqueous Iodine Solution 5% for Hyperthyroidism|Graves' disease|Toxic nodular goiter. None/Not specified-controlled. 182 participants.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Hyperthyroidism|Graves' disease|Toxic nodular goiter
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-08-2024
- First CTIS Authorization Date
- 15-08-2024
Trial design
None/Not specified-controlled trial in Sweden.
- Comparator
- None/Not specified
- Target Sample Size
- 182
Eligibility
Recruits 182 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (age 18-75). No assent or special consent handling for vulnerable groups is described in the record..
- Pregnancy Exclusion
- Pregnancy Breast feeding Women with childbearing potential not using contraception
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (age 18-75). No assent or special consent handling for vulnerable groups is described in the record.
Inclusion criteria
- {"criterion_text":"- Pilot study: Hyperthyroidism due to toxic nodular goiter. Age 18-75 years. Main study: Hyperthyroidism due to toxic nodular goiter and Grave's disease accepted for thyroidectomy. Age 18-75 years."}
Exclusion criteria
- {"criterion_text":"- Unstable coronary artery disease Previous thyroid surgery Congestive heart failure Renal failure Liver failure Current infection Ongoing treatment with glucocorticoids Ongoing treatment with anticoagulants Thyroid associated ophtalmopathy CAS >2 Diabetes mellitus type1 Active cancer Severe psychiatric illness Amiodarone treatment Pregnancy Breast feeding Women with childbearing potential not using contraception Unability to comprehend the meaning of the study Iodine hypersensitivity"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Pilot study: Response of TSH, fT4, fT3 and heart rate after 10 days of administration of iodine solution.","definition_or_measurement_approach":"Pilot study: Serum levels of TSH, fT4, fT3 and heart rate day 0, day 3-4, day 6-7 and day 10 after administration of iodine solution."}
- {"endpoint_text":"- Main study: Occurance of postoperative temporary hypoparathyroidism.","definition_or_measurement_approach":"Main study: Immediately postoperatively and 1 month post surgery"}
Secondary endpoints
- {"endpoint_text":"- Pilot study: evaluation of quality of life after treatment with iodine solution.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Main study: Occurance of postoperative permanent hypoparathyroidism.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Main study: Occurance of postoperative temporary and permanent recurrant nerve palsy.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Evaluation of quality of Life.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 182
- Recruitment Window Months
- 45
- Consent Approach
- Subject information and informed consent forms are listed in the documents (multiple versions). Participants are adults (18-75). No further details on assent or specific consent processes/languages are provided in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 182
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 15-08-2024
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 182
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Endocrinology
- Principal Investigator Name
- Jan Calissendorff
- Principal Investigator Email
- jan.calissendorff@regionstockholm.se
- Contact Person Name
- Jan Calissendorff
- Contact Person Email
- jan.calissendorff@regionstockholm.se
- Number Of Participants
- 182
Sponsor
Primary sponsor
- Full Name
- Karolinska University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Aqueous Iodine Solution 5%
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Maximum Dose
- 100.5 mg per day
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