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Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03094416
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : May 24, 2021
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Brief 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 TSH upon switch to Tirosint with respect to baseline.

Condition or disease Intervention/treatment Phase
Hypothyroidism;Postablative Drug: levothyroxine sodium capsule Drug: Proton pump inhibitor Drug: Levothyroxine Sodium Tablets Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: levothyroxine sodium capsules
levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months
Drug: levothyroxine sodium capsule
after the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in
Other Name: Tirosint

Drug: Proton pump inhibitor
for the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion
Other Name: omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole

Drug: Levothyroxine Sodium Tablets
during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion

Primary Outcome Measures :
  1. TSH (Thyroid Stimulating Hormone) [ Time Frame: 6 weeks and 12 weeks ]
    change in serum levels of TSH upon switch to levothyroxine sodium capsules with respect to baseline

Secondary Outcome Measures :
  1. FT4 (free thyroxine) [ Time Frame: 6 weeks and 12 weeks ]
    change in serum levels of FT4 with respect to baseline

  2. TT4 (total thyroxine) [ Time Frame: 12 weeks ]
    change in serum levels of TT4 with respect to baseline

  3. FT3 (free triiodothyronine) [ Time Frame: 6 weeks and 12 weeks ]
    change in serum levels of FT3 with respect to baseline

  4. TT3 (total triiodothyronine) [ Time Frame: 6 weeks and 12 weeks ]
    change in serum levels of TT3 with respect to baseline

Other Outcome Measures:
  1. CPK (creatine phosphokinase) [ Time Frame: 12 weeks ]
    changes in CPK towards baseline

  2. SHBG (sex hormone binding globulin) [ Time Frame: 12 weeks ]
    changes in SHBG towards baseline

  3. ferritin [ Time Frame: 12 weeks ]
    changes in ferritin towards baseline

  4. ACE (angiotensin converting enzyme) [ Time Frame: 12 weeks ]
    changes in ACE towards baseline

  5. lipid panel [ Time Frame: 12 weeks ]
    changes in lipid panel towards baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. written informed consent duly read, signed and dated by the subject;
  2. aged ≥18 and ≤65 years;
  3. history of hypothyroidism due to total thyroidectomy;
  4. on stable LT4 doses for at least 6 weeks at screening (≥88 mcg daily and ≤250 mcg daily);
  5. TSH at screening ≥0.3 and ≤4.0 mIU/L;
  6. 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;
  7. for women, adequate and continuative contraceptive measures until the end of the study, if not in menopause;
  8. reasonable assumption of understanding the study and willingness to take part to the study and to comply with protocol requirements.

Exclusion Criteria:

  1. suspected or ascertained non-compliance with LT4 or PPI therapy;
  2. subject requiring changes of levothyroxine dose;
  3. use of over-the-counter (OTC) PPIs;
  4. 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;
  5. 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);
  6. neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology);
  7. terminal condition;
  8. parenteral or assisted enteral feeding;
  9. 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;
  10. history of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements;
  11. pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months;
  12. known hypersensitivity to the ingredients of the preparation involved in the study3;
  13. use of forbidden concomitant medications;
  14. regular consumption of soy and soy derivatives, cotton seed meals, walnuts, and dietary fibres;
  15. participation in other clinical studies during the 3 months prior to screening;
  16. presumption of poor reliability/cooperation;
  17. any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03094416

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United States, California
California Head and Neck Specialists
La Jolla, California, United States, 92037
Coastal Metabolic Research Centre
Ventura, California, United States, 93003
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010-2975
United States, Maryland
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, New York
NYC Health + Hospitals/ Queens
New York, New York, United States, 11432
United States, North Carolina
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States, 28557
United States, South Carolina
Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, United States, 29118
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Stonesifer Endocrine Care & Clinical Research Inc., PS
Federal Way, Washington, United States, 98003
Sponsors and Collaborators
IBSA Institut Biochimique SA
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Principal Investigator: Kenneth D Burman, MD Medstar Health Research Institute
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Responsible Party: IBSA Institut Biochimique SA Identifier: NCT03094416    
Other Study ID Numbers: 13US-T404
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action