LISA-study : Levothyroxin in Nodular Goiter

Goiter, Nodular Clinical Trial

Official title:

TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277589
• Other study ID #: L_9133
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2006
• Last updated: December 3, 2009
• Start date: May 2004
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter
• Goiter, Nodular

Intervention

Drug:
• Levothyroxin-Na
1 tablet 30 minutes before breakfast
• Levothyroxine-Na + iodide
1 tablet 30 minutes before breakfast
• Iodide
1 tablet 30 minutes before breakfast
• Placebo
1 tablet 30 minutes before breakfast

Locations

Country	Name	City	State
Germany	Sanofi-Aventis Administrative Office	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		after 12 months of treatment	No
Secondary	The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment after 12 months treatment.		after 12 months treatment	No
Secondary	Additionally, the change in the number of nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.		after 12 months treatment	No
Secondary	Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.		after 12 months treatment	No