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Clinical Trials/EUCTR2014-000574-19-IT
EUCTR2014-000574-19-IT
Active, not recruiting
Phase 1

Experimental study for the evaluation of the effect of radioactive iodine therapy on free thyroxine circulating levels after oral administration of sodium levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer . - Free thyroxine circulating levels after radioactive iodine therapy

AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA0 sites30 target enrollmentFebruary 20, 2014
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Conditionspatients thyroidectomized for differentiated thyroid cancerMedDRA version: 16.1Level: LLTClassification code 10057242Term: Post surgical hypothyroidismSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Hormonal diseases [C19]
DrugsTirosint® SOLUZIONE ORALETirosint®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
patients thyroidectomized for differentiated thyroid cancer
Sponsor
AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
Enrollment
30
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 20, 2014
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Adult patients thyroidectomized for differentiated thyroid cancer
  • •\-Written informed consent to partecipate in the study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 20
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •\-Patients who will undergo radioactive iodine therapy in a hypothyroid state
  • •\-Inflammatory bowel diseases
  • •\-Malabsorption, chronic gastritis
  • •\-Treatment with estrogens, selective estrogen receptor modulators, drugs known to modify Levo\-thyroxine absorption (i.e.: proton pump inhibitors, resins, iron, sucralfate, calcium, alluminum, chemotherapy, immunosuppressive therapy)
  • •\-Previous radiotherapy or radioactive iodine therapy
  • •\-Pregnancy
  • •\-Organ failure or other disease known to limit life expectancy
  • •\-History of chronic inflammatory/infectious/autoimmune diseases
  • •\-Any abnormality found during clinical examination at the screening visit, which according to the opinion of the investigator may be harmful for the patient in order to complete the study
  • •\-History of low compliance or psychiatric illness or any other condition which make the study inappropriate

Outcomes

Primary Outcomes

Not specified

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