ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2010-018663-42-IT
Date of registration:	15/06/2010
Prospective Registration:	Yes
Primary sponsor:	BRACCO
Public title:	Substitutive therapy of hypothyroid patients with L-thyroxine (T4) plus T3 sulfate (T3S). A Phase II, open-label, single centre, parallel group study on therapeutic efficacy and tolerability - ND
Scientific title:	Substitutive therapy of hypothyroid patients with L-thyroxine (T4) plus T3 sulfate (T3S). A Phase II, open-label, single centre, parallel group study on therapeutic efficacy and tolerability - ND
Date of first enrolment:	15/06/2010
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018663-42
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Italy

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Patients will be enrolled if they meet all the following inclusion criteria: written informed consent obtained; outpatients of either sex, aged between 18 and 70 years; hypothyroid for any raison, in T4 substitutive therapy (daily dose: 100/125/150 mcg); undetectable Tg (<5) (absence of endogenous thyroid hormones production); acceptable metabolic control (FT4, FT3 and TSH values inside the normal ranges); patient’s co-operative attitude and able to understand and adhere to study protocol procedures and timelines.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients will not be enrolled if they meet any of the following exclusion criteria: history or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; history or current evidence of significant liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; assumption of drugs affecting thyroid hormone GI absorption or metabolism; any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations; immunocompromised patients; malignant disease or any other disease with life expectancy less than 2 years; history of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; artificial or parenteral feeding; allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; patients who received any investigational drug within the last 3 months; patients who have been previously enrolled in this study; employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Thyroidectomized patients without endogenous hormonal production (Tg<5) in stable substitutive therapy with T4
MedDRA version: 9.1 Level: LLT Classification code 10021117

Intervention(s)

Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Other descriptive name: T3-sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-

Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Other descriptive name: T3-sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-

Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Other descriptive name: T3-sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 60-

Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Other descriptive name: T3-sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 80-

Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Other descriptive name: T3-sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: EUTIROX*50CPR 75MCG
Pharmaceutical Form: Tablet
INN or Proposed INN: Levothyroxine sodium
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: EUTIROX*50CPR 100MCG
Pharmaceutical Form: Tablet
INN or Proposed INN: Levothyroxine sodium
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: EUTIROX*50CPR 125MCG
Pharmaceutical Form: Tablet
INN or Proposed INN: Levothyroxine sodium
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Main Objective: The primary objective of the study is to check the possibility of maintain the metabolic control, evaluated on the basis of the TT3, FT3, FT4 and TSH circulating levels, obtained in hypothyroid patients with the T4 administration, partially substituting the T4 dose with T3S.

Secondary Objective: The secondary objectives of the study are to check the safety of T3S prolonged administration; to find the optimal T4/T3S substitutive ratio; to compare the judgment of the patients on T4 vs T4+T3S therapy.

Primary end point(s): The primary efficacy variable will be the responder variable: patients will be considered as responders if metabolic control is maintained (independently of the T3S previous dose administered) within the visit V3c

Secondary Outcome(s)

Secondary ID(s)

T3S01-10

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.