NCT00277589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,024

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

4.6 years

First QC Date

January 13, 2006

Last Update Submit

December 3, 2009

Conditions

Goiter, Nodular

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • 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

  • Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.

    after 12 months treatment

Study Arms (4)

1

EXPERIMENTAL
Drug: Levothyroxine-Na + iodide

2

ACTIVE COMPARATOR
Drug: Levothyroxin-Na

3

ACTIVE COMPARATOR
Drug: Iodide

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Levothyroxin-NaDRUG

1 tablet 30 minutes before breakfast

2
Levothyroxine-Na + iodideDRUG

1 tablet 30 minutes before breakfast

1
IodideDRUG

1 tablet 30 minutes before breakfast

3
PlaceboDRUG

1 tablet 30 minutes before breakfast

4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Frankfurt, Germany

Location

MeSH Terms

Conditions

Goiter, Nodular

Interventions

Iodides

Condition Hierarchy (Ancestors)

GoiterThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsIodine Compounds

Study Officials

  • Katrin Roscher

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

DE(1)