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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
  Purpose

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 Intervention Phase
Goiter, Nodular
 Drug: Levothyroxin-Na
Drug: Levothyroxine-Na + iodide
Drug: Iodide
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1024
Study Start Date: May 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277589

Locations
Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Katrin Roscher Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00277589     History of Changes
Other Study ID Numbers: L_9133
Study First Received: January 13, 2006
Last Updated: December 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Goiter
Goiter, Nodular
Thyroid Diseases
Endocrine System Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013