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LISA-study : Levothyroxin in Nodular Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00277589
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : December 4, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Goiter, Nodular Drug: Levothyroxin-Na Drug: Levothyroxine-Na + iodide Drug: Iodide Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter
Study Start Date : May 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Levothyroxine-Na + iodide
1 tablet 30 minutes before breakfast
Active Comparator: 2 Drug: Levothyroxin-Na
1 tablet 30 minutes before breakfast
Active Comparator: 3 Drug: Iodide
1 tablet 30 minutes before breakfast
Placebo Comparator: 4 Drug: Placebo
1 tablet 30 minutes before breakfast


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment. [ Time Frame: after 12 months treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277589


Locations
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Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Katrin Roscher Sanofi
More Information
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00277589    
Other Study ID Numbers: L_9133
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Goiter
Goiter, Nodular
Thyroid Diseases
Endocrine System Diseases
Iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Physiological Effects of Drugs