LISA-study : Levothyroxin in Nodular Goiter - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00277589

Purpose

Primary objective:

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 IV

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:

Drug Information available for: Thyroxine Levothyroxine Sodium Levothroid Iodine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

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-Aventis

Investigators

Study Director:

Katrin Roscher

Sanofi-Aventis

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 February 12, 2012