LISA-Study : Levothyroxin in Nodular Goiter - Tabular View

Tracking Information

First Received Date ^ICMJE

January 13, 2006

Last Updated Date

January 6, 2009

Start Date ^ICMJE

May 2004

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00277589 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment after 12 months treatment.
Additionally, the change in the number of nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
Echogenity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.

Descriptive Information

Brief Title ^ICMJE

LISA-Study : Levothyroxin in Nodular Goiter

Official Title ^ICMJE

TSH-Adapted Therapy in a Large Randomized, Observer-Blind, Placebo-Controlled, Prospective Treatment Study of Patients With Nodular Goiter

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Goiter, Nodular

Intervention ^ICMJE

Drug: Levothyroxin-Na
Drug: Levothyroxine-Na + iodide
Drug: Iodide
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

983

Completion Date

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00277589

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

L_9133

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Katrin Roscher

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

December 2008

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