LISA-study : Levothyroxin in Nodular Goiter

• ClinicalTrials.gov Identifier: NCT00277589
• Recruitment Status: Completed
• First Posted: January 16, 2006
• Last Update Posted: December 4, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: January 13, 2006
• First Posted Date: January 16, 2006
• Last Update Posted Date: December 4, 2009
• Study Start Date: May 2004
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 25, 2008): 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 ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: July 17, 2008)

• 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 ]
• 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 ]
• Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment. [ Time Frame: after 12 months treatment ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LISA-study : Levothyroxin in Nodular Goiter
• Official Title: 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Goiter, Nodular

Intervention

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

Study Arms

• Experimental: 1
  Intervention: Drug: Levothyroxine-Na + iodide
• Active Comparator: 2
  Intervention: Drug: Levothyroxin-Na
• Active Comparator: 3
  Intervention: Drug: Iodide
• Placebo Comparator: 4
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 3, 2009): 1024
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00277589
• Other Study ID Numbers: L_9133
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medical Affairs Study Director, sanofi-aventis
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Katrin Roscher; Sanofi

• PRS Account: Sanofi
• Verification Date: December 2009