Multicentre, controlled, randomised, open-label, cross-over clinical study of the efficacy and tolerability of L-thyroxine (T4) soft capsules, in comparison to L-thyroxine tablets, in thyroidectomised patients.
- Conditions
- Post- operation hypothyroidismMedDRA version: 9.1Level: LLTClassification code 10021117Term: Hypothyroidism postoperative
- Registration Number
- EUCTR2006-002614-36-FR
- Lead Sponsor
- IBSA, Institut Biochimique SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 205
-outpatients, either men or women between 18 and 75
- Having undergone a total hypothyrodism, whatever the reason is, having consequently ahypothyroidism biological state.
- undectable rate in thyroglobulin (<1 microgram/L) and self-antibodies of the thyroglobulin during the selection
- substitutive treatment or suppression of TSH with T4 tablets at a stable dosis at least for 3 months, stable metabolic status, patient who is available to take part to the study and able to understand the protocol and to respect it.
- patient who has given his/her written consent
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
-Functional severe cardiac (cardiac insufficiency), renal, respiratory hepatitic problems
-metabolic diseases (e.g. unbalanced diabet of type II) organic (liver cirrhosis), endocrinal or systemic diseases (except the disease under study), current or abated neoplastic diseases for less than 5 years (except the disease un der study)
-terminal phase
-patient under parental or assisted nutrition
-pregnant women or likely to become in the next 12 months
-lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the therapeutic activity of L-thyroxine soft capsules with oral use to L-thyroxine tablets.;Secondary Objective: To evaluate the tolerability of the new formulation with the patients acceptance for the product.;Primary end point(s): blood dosage of free T4
- Secondary Outcome Measures
Name Time Method