Goiter, NodularPhase 4NCT00277589
LISA-study : Levothyroxin in Nodular Goiter
A Phase 4 study testing Levothyroxin-Na, Levothyroxine-Na + iodide and Iodide in people with Goiter, Nodular, run by Sanofi at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Goiter, Nodular
- What is being tested?
- Levothyroxin-Na, Levothyroxine-Na + iodide and Iodide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,024 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter
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.
- Conditions
- Goiter, Nodular
- Being tested
- Levothyroxin-Na, Levothyroxine-Na + iodide, Iodide, Placebo
- Medical subject headings
- Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxin-NaDrug
1 tablet 30 minutes before breakfast
Levothyroxine-Na + iodideDrug
1 tablet 30 minutes before breakfast
IodideDrug
1 tablet 30 minutes before breakfast
PlaceboDrug
1 tablet 30 minutes before breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Levothyroxine-Na + iodide |
| 2 | Active comparator | Not described Receives: Drug: Levothyroxin-Na |
| 3 | Active comparator | Not described Receives: Drug: Iodide |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: after 12 months treatment
Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
Measured: after 12 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startMay 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Goiter, NodularStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katrin Roscher, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277589
- Sponsor's protocol ID
- L_9133
- Status last verified
- Dec 2009
- First submitted
- 13 Jan 2006
- Last updated
- 4 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter
- ClinicalTrials.gov ID
- NCT00277589
- Acronym / sponsor ID
- L_9133
- Conditions
- Goiter, Nodular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levothyroxine-Na + iodide |
| 2 | Active comparator | Drug: Levothyroxin-Na |
| 3 | Active comparator | Drug: Iodide |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levothyroxin-Na1 tablet 30 minutes before breakfast | Drug | 2 |
| Levothyroxine-Na + iodide1 tablet 30 minutes before breakfast | Drug | 1 |
| Iodide1 tablet 30 minutes before breakfast | Drug | 3 |
| Placebo1 tablet 30 minutes before breakfast | Drug | 4 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin Roscher study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxin-Na, Levothyroxine-Na + iodide and Iodide in people with Goiter, Nodular, run by Sanofi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009.