Hypothyroidism;PostablativePhase 4NCT03094416
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
A Phase 4 study testing levothyroxine sodium capsule, Proton pump inhibitor (PPI) and Levothyroxine Sodium (LT4) Tablets in people with Hypothyroidism;Postablative, run by IBSA Institut Biochimique SA at 9 sites in United States.
Trial summary
This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating changes in serum levels of Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with respect to baseline. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypothyroidism;Postablative
- What is being tested?
- levothyroxine sodium capsule, Proton pump inhibitor (PPI) and Levothyroxine Sodium (LT4) Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Jul 2018to 15 Jun 2020
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent duly read, signed and dated by the subject;
- aged ≥18 and ≤65 years;
- history of hypothyroidism due to total thyroidectomy;
- on stable LT4 doses for at least 6 weeks at screening (≥88 mcg daily and ≤250 mcg daily);
- TSH at screening ≥0.3 and ≤4.0 mIU/L;
- history of gastroesophageal reflux disease or associated gastrointestinal issues on prescription PPIs (i.e. omeprazole ≥20 mg daily, or esomeprazole ≥ 20 mg daily, or lansoprazole ≥ 15 mg daily, or pantoprazole ≥ 40 mg daily) for at least 8 weeks before screening visit and for whom chronic therapy with PPIs for the next 5 months has been prescribed;
- for women, adequate and continuative contraceptive measures until the end of the study, if not in menopause;
- reasonable assumption of understanding the study and willingness to take part to the study and to comply with protocol requirements.
Who cannot join
- suspected or ascertained non-compliance with LT4 or PPI therapy;
- subject requiring changes of levothyroxine dose;
- use of over-the-counter (OTC) PPIs;
- history of malabsorption or history of gastric bypass surgery, short-gut syndrome, inflammatory bowel disease and other conditions of the gastrointestinal tract that may affect drug absorption (e.g. celiac disease)3;
- multiple co-morbidities (e.g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/or respiratory functions);
- neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology);
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- terminal condition;
- parenteral or assisted enteral feeding;
- presence of any medical condition or other circumstances which would significantly affect the safety of the subject or decrease the chance of obtaining reliable data, achieving study objectives or completing the study;
- history of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements;
- pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months;
- known hypersensitivity to the ingredients of the preparation involved in the study3;
- use of forbidden concomitant medications;
- regular consumption of soy and soy derivatives, cotton seed meals, walnuts, and dietary fibres;
- participation in other clinical studies during the 3 months prior to screening;
- presumption of poor reliability/cooperation;
- any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Stonesifer Endocrine Care & Clinical Research Inc., PS
Federal Way, Washington, 98003
California Head and Neck Specialists
La Jolla, California, 92037
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557
NYC Health + Hospitals/ Queens
New York, New York, 11432
Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, 29118
Virginia Commonwealth University
Richmond, Virginia, 23298
Coastal Metabolic Research Centre
Ventura, California, 93003
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975
About this study
Official title: An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors
This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating changes in serum levels of Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with respect to baseline.
- Conditions
- Hypothyroidism;Postablative
- Being tested
- levothyroxine sodium capsule, Proton pump inhibitor (PPI), Levothyroxine Sodium (LT4) Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levothyroxine sodium capsuleDrug
Also called Tirosint
after the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in
Proton pump inhibitor (PPI)Drug
Also called omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole
for the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion
Levothyroxine Sodium (LT4) TabletsDrug
during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion
| Study group | Role | What they receive |
|---|---|---|
| levothyroxine sodium capsules | Experimental | levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months Receives: Drug: levothyroxine sodium capsule; Drug: Proton pump inhibitor (PPI); Drug: Levothyroxine Sodium (LT4) Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid Stimulating Hormone (TSH)
Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline
Measured: baseline and 12 weeks
Secondary outcomes (4)
Free Thyroxine (FT4)
Change in Serum Levels of FT4 (free thyroxine) from Baseline
Measured: baseline and 12 weeks
Total Thyroxine (TT4)
Change in Serum Levels of TT4 (total thyroxine) from Baseline
Measured: baseline and 12 weeks
Free Triiodothyronine (FT3)
Change in Serum Levels of FT3 (free triiodothyronine) from Baseline
Measured: baseline and 12 weeks
Total Triiodothyronine (TT3)
Change in Serum Levels of TT3 (total triiodothyronine) from Baseline
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start30 Jul 2018
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothyroidism;PostablativeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth D Burman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094416
- Sponsor's protocol ID
- 13US-T404
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2017
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sachmechi I, Lucas KJ, Stonesifer LD, Ansley JF, Sack P, Celi FS, Scarsi C, Lanzi G, Wartofsky L, Burman KD. Efficacy of Levothyroxine Sodium Soft Gelatin Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors: An Open-Label Study. Thyroid. 2023 Dec;33(12):1414-1422. doi: 10.1089/thy.2023.0382. Epub 2023 Nov 16.
PubMed 37885233
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT03094416
- Acronym / sponsor ID
- 13US-T404
- Conditions
- Hypothyroidism;Postablative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating changes in serum levels of Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with respect to baseline.
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 capsules | Experimental | Drug: levothyroxine sodium capsule, Drug: Proton pump inhibitor (PPI), Drug: Levothyroxine Sodium (LT4) Tabletslevothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- written informed consent duly read, signed and dated by the subject;
- aged ≥18 and ≤65 years;
- history of hypothyroidism due to total thyroidectomy;
- on stable LT4 doses for at least 6 weeks at screening (≥88 mcg daily and ≤250 mcg daily);
- TSH at screening ≥0.3 and ≤4.0 mIU/L;
Key exclusion criteria (17 listed)
- suspected or ascertained non-compliance with LT4 or PPI therapy;
- subject requiring changes of levothyroxine dose;
- use of over-the-counter (OTC) PPIs;
- history of malabsorption or history of gastric bypass surgery, short-gut syndrome, inflammatory bowel disease and other conditions of the gastrointestinal tract that may affect drug absorption (e.g. celiac disease)3;
- multiple co-morbidities (e.g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/or respiratory functions);
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 capsuleAlso: Tirosintafter the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in | Drug | levothyroxine sodium capsules |
| Proton pump inhibitor (PPI)Also: omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazolefor the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion | Drug | levothyroxine sodium capsules |
| Levothyroxine Sodium (LT4) Tabletsduring the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion | Drug | levothyroxine sodium capsules |
Primary outcome
Thyroid Stimulating Hormone (TSH)
Time frame: baseline and 12 weeks
Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline
4 secondary outcomes
Free Thyroxine (FT4)
Time frame: baseline and 12 weeks
Total Thyroxine (TT4)
Time frame: baseline and 12 weeks
Free Triiodothyronine (FT3)
Time frame: baseline and 12 weeks
Total Triiodothyronine (TT3)
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37885233Sachmechi I, Lucas KJ, Stonesifer LD, Ansley JF, Sack P, Celi FS, Scarsi C, Lanzi G, Wartofsky L, Burman KD. Efficacy of Levothyroxine Sodium Soft Gelatin Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors: An Open-Label Study. Thyroid. 2023 Dec;33(12):1414-1422. doi: 10.1089/thy.2023.0382. Epub 2023 Nov 16.
- Individual participant dataSharing planned: No
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.
Kenneth D Burman, MD principal investigator
Medstar Health Research Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levothyroxine sodium capsule, Proton pump inhibitor (PPI) and Levothyroxine Sodium (LT4) Tablets in people with Hypothyroidism;Postablative, run by IBSA Institut Biochimique SA at 9 sites in United States.
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 8 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 5 Apr 2022). 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?
Thyroid Stimulating Hormone (TSH) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094416, which also lists 1 linked publication.
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 5 Apr 2022.