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LISA-study : Levothyroxin in Nodular Goiter

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00277589
First received: January 13, 2006
Last updated: December 3, 2009
Last verified: December 2009
History of Changes

January 13, 2006
December 3, 2009
May 2004
December 2008   (final data collection date for primary outcome measure)
The primary outcome measure is to compare the change in total volume of all nodules after 12 months Levothyroxin treatment to the change after 12 months of each of the reference treatments (one of the two active controls or placebo) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00277589 on ClinicalTrials.gov Archive Site
  • The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment after 12 months treatment. [ Time Frame: after 12 months treatment ] [ Designated as safety issue: No ]
  • Additionally, the change in the number of nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment. [ Time Frame: after 12 months treatment ] [ Designated as safety issue: No ]
  • Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment. [ Time Frame: after 12 months treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
LISA-study : Levothyroxin in Nodular Goiter
TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter

Primary objective:

  • To evaluate change in total volume of all nodules.

Secondary objectives:

  • To evaluate change in goiter volume after a 12-months treatment, number of nodules and echogenicity of nodules.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Goiter, Nodular
  • Drug: Levothyroxin-Na
    1 tablet 30 minutes before breakfast
  • Drug: Levothyroxine-Na + iodide
    1 tablet 30 minutes before breakfast
  • Drug: Iodide
    1 tablet 30 minutes before breakfast
  • Drug: Placebo
    1 tablet 30 minutes before breakfast
  • Experimental: 1
    Intervention: Drug: Levothyroxine-Na + iodide
  • Active Comparator: 2
    Intervention: Drug: Levothyroxin-Na
  • Active Comparator: 3
    Intervention: Drug: Iodide
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1024
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Caucasian
  • Normal TSH value (target range between 0.6 - 3.0 mU/l)
  • Thyroid nodules in a normal sized or enlarged thyroid at least one nodule (smaller/equal 20 % of volume with cystic change) with greater/equal 1.0 cm diameter, for nodules greater 1.0 cm the diagnosis must be performed according to the guideline for diagnostic standards of thyroid disorders.

Exclusion Criteria:

  • Thyroid therapy within the last 3 years
  • Known focal or diffuse structure autonomous thyroid
  • Contraindication to iodine
  • Concomitant treatment with iodine containing medication (i.e. amiodarone)
  • Use of iodine-containing contrast medium within the last 6 weeks
  • Presence of TPO antibodies (maximum two fold normal value)
  • Symptomatic coronary heart disease
  • Endocrine orbitopathy
  • Known autoimmune thyreopathy
  • Former radioiodine therapy or surgery
  • Dermatitis herpetiformis
  • Pathological laboratory results
  • Participation in another clinical study with investigational medication within the last 30 days
  • Pregnant or nursing female patients
  • Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
  • Severe or unstable cardiovascular diseases (e.g. severe angina pectoris, postmyocardial infarction syndrome and ventricular extrasystoles, symptomatic coronary heart disease), clinically relevant renal or hepatic diseases or disorders, any other clinically relevant condition that might enhance the risk for the study participant.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00277589
L_9133
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Katrin Roscher Sanofi
Sanofi
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP