HypothyroidismPhase 2NCT01916304
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
A Phase 2 study testing Levothyroxine sodium new formulation in people with Hypothyroidism, run by Takeda at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine sodium new formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Near) total thyroidectomised patients.
- Aged 18 years and older.
- Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.
- Written informed consent given.
- Able and willing to comply with protocol requirements and to complete the study.
Who cannot join
- History of Graves' disease or positive TSH-receptor antibodies.
- History of thyroid cancer requiring TSH suppression.
- Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
- Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
- Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
- Participation in another trial in the past 6 weeks.
- Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open-label Switch Study to Investigate the Necessity of Dose Adjustment After Switching From L-Thyroxine Christiaens® to the New Levothyroxine Sodium Test Formulation in (Near) Total Thyroidectomised Patients.
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.
Read the detailed description
The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation.
The results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation.
The study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks).
All participants will be asked to take a daily dose at the same time each day throughout the study.
This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine sodium new formulation
- Keywords
- Drug Therapy
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine sodium new formulationDrug
Levothyroxine tablets
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine sodium new formulation | Experimental | Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. Receives: Drug: Levothyroxine sodium new formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Do Not Need a Change of Dose
Dose change was determined by physician according to their clinical judgement.
Measured: 2 months (± 2 weeks) after switch to sodium formulation.
Secondary outcomes (4)
Magnitude of the Change in Daily Dose Needed
Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.
Measured: 2 months (± 2 weeks) after switch to sodium formulation.
Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L
Blood samples were collected and samples were analyzed according to the local Quality System.
Measured: Month 4 (± 4 weeks) after inclusion into study.
Absolute Serum Thyroid Stimulating Hormone Values
Blood samples were collected and samples were analyzed according to the local Quality System.
Measured: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone
Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.
Measured: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916304
- Sponsor's protocol ID
- LE-9999-401-BE
- Other IDs
- 2012-005732-28, U1111-1145-3526
- Status last verified
- Jun 2015
- First submitted
- 1 Aug 2013
- Last updated
- 20 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label Switch Study to Investigate the Necessity of Dose Adjustment After Switching From L-Thyroxine Christiaens® to the New Levothyroxine Sodium Test Formulation in (Near) Total Thyroidectomised Patients.
- ClinicalTrials.gov ID
- NCT01916304
- Acronym / sponsor ID
- LE-9999-401-BE
- Conditions
- Hypothyroidism
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Posted 20 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.
Detailed description
The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation.
The results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation.
The study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks).
All participants will be asked to take a daily dose at the same time each day throughout the study.
This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine sodium new formulation | Experimental | Drug: Levothyroxine sodium new formulationLevothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (Near) total thyroidectomised patients.
- Aged 18 years and older.
- Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.
- Written informed consent given.
- Able and willing to comply with protocol requirements and to complete the study.
Key exclusion criteria (7 listed)
- History of Graves' disease or positive TSH-receptor antibodies.
- History of thyroid cancer requiring TSH suppression.
- Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
- Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
- Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
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 |
|---|---|---|
| Levothyroxine sodium new formulationLevothyroxine tablets | Drug | Levothyroxine sodium new formulation |
Primary outcome
Percentage of Participants That Do Not Need a Change of Dose
Time frame: 2 months (± 2 weeks) after switch to sodium formulation.
Dose change was determined by physician according to their clinical judgement.
4 secondary outcomes
Magnitude of the Change in Daily Dose Needed
Time frame: 2 months (± 2 weeks) after switch to sodium formulation.
Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L
Time frame: Month 4 (± 4 weeks) after inclusion into study.
Absolute Serum Thyroid Stimulating Hormone Values
Time frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone
Time frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Responsible study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levothyroxine sodium new formulation in people with Hypothyroidism, run by Takeda at 1 site in Belgium.
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 5 inclusion and 7 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 20 Jul 2015. 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 Belgium. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants That Do Not Need a Change of Dose (time frame: 2 months (± 2 weeks) after switch to sodium formulation.). 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 20 Jul 2015.