Overview
Sponsor-declared trial summary
Hyperthyroidism
Pilot study: To investigate the effect of iodine solution on toxic nodular goiter. Can it be administered safely to patients with toxic nodular goiter? How are the thyroid hormones and clinical status affected? Main study: Does preoperative treatment with iodine solution reduce the postoperative risk of temporary hypo…
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 15 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517110-15-00
- EudraCT number
- 2019-002242-21
- ClinicalTrials.gov
- NCT04856488
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
Pilot study: To investigate the effect of iodine solution on toxic nodular goiter. Can it be administered safely to patients with toxic nodular goiter? How are the thyroid hormones and clinical status affected? Main study: Does preoperative treatment with iodine solution reduce the postoperative risk of temporary hypoparathyroidism in patients with toxic nodular goiter and Graves' disease undergoing thyroidectomy?
Secondary objectives 1
- Pilot study: Is quality of life affected by administration of iodine solution in toxic nodular goiter? Main study: Does preoperative treatment with iodine solution reduce the risks of permanent hypoparathyroidism, temporary and permanent recurrent nerve palsy and affect quality of life in patients with toxic nodular goiter and Grave's disease undergoing thyroidectomy. How are the thyroid blood vessels affected by administration of iodine solution? Are the endothelium or other vascular structures affected? Preclinical study on the resected thyroid tissues from the main study.
Conditions and MedDRA coding
Hyperthyroidism
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10020850 | Hyperthyroidism | 100000004860 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516013-20-00 | Preoperative Lugol’s solution in Graves’ disease and toxic nodular goiter | Karolinska University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- Pilot study: Response of TSH, fT4, fT3 and heart rate after 10 days of administration of iodine solution. Main study: Occurance of postoperative temporary hypoparathyroidism. 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. Main study: Immediately postoperatively and 1 month post surgery
Secondary endpoints 1
- Pilot study: evaluation of quality of life after treatment with iodine solution. Main study: Occurance of postoperative permanent hypoparathyroidism. Occurance of postoperative temporary and permanent recurrant nerve palsy. Evaluation of quality of Life.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
-
A01AD · Product
- Pharmaceutical form
- PHF00001MIG
- Route of administration
- ORAL USE
- Max daily dose
- 100.5 mg milligram(s)
- Max total dose
- 1005 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- A01AD — OTHER AGENTS FOR LOCAL ORAL TREATMENT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- [email protected]
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- [email protected]
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 182 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-08-15 | 2024-08-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protokoll_version2 | 1 |
| Recruitment arrangements (for publication) | Placeholder | 1 |
| Subject information and informed consent form (for publication) | Patientinfo_version2_Graves | 1 |
| Subject information and informed consent form (for publication) | Patientinfo_version2_pilot | 1 |
| Subject information and informed consent form (for publication) | Patientinfo_version2_ToxiskKnolstruma | 1 |
| Subject information and informed consent form (for publication) | Patientinfo_version2_Vavnadsstudie | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_JodjodkaliumAPL | 1 |
| Synopsis of the protocol (for publication) | synopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Sweden | Acceptable with conditions 2024-08-15
|
2024-08-15 |