Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Phase 4

Completed

• Conditions: Hypothyroidism;Postablative
• Interventions: Drug: levothyroxine sodium capsule; Drug: Proton pump inhibitor (PPI); Drug: Levothyroxine Sodium (LT4) Tablets

• Registration Number: NCT03094416
• Lead Sponsor: 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 Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with respect to baseline.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-29
• Study Start: 2018-07-30
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Disposition First Submitted: 2021-05-10
• Results First Submitted: 2022-02-04
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-01
• Disposition First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-01
• Results First Posted: 2022-04-05
• Disposition First Posted: 2022-04-05
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
levothyroxine sodium capsules	levothyroxine sodium capsule	levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months
levothyroxine sodium capsules	Proton pump inhibitor (PPI)	levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months
levothyroxine sodium capsules	Levothyroxine Sodium (LT4) Tablets	levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months

Primary Outcome Measures

Name	Time	Method
Thyroid Stimulating Hormone (TSH)	baseline and 12 weeks	Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline

Secondary Outcome Measures

Name	Time	Method
Free Thyroxine (FT4)	baseline and 12 weeks	Change in Serum Levels of FT4 (free thyroxine) from Baseline
Total Thyroxine (TT4)	baseline and 12 weeks	Change in Serum Levels of TT4 (total thyroxine) from Baseline
Free Triiodothyronine (FT3)	baseline and 12 weeks	Change in Serum Levels of FT3 (free triiodothyronine) from Baseline
Total Triiodothyronine (TT3)	baseline and 12 weeks	Change in Serum Levels of TT3 (total triiodothyronine) from Baseline

Trial Locations

Locations (9)

California Head and Neck Specialists; 🇺🇸 La Jolla, California, United States

Coastal Metabolic Research Centre; 🇺🇸 Ventura, California, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

MedStar Union Memorial Hospital; 🇺🇸 Baltimore, Maryland, United States

NYC Health + Hospitals/ Queens; 🇺🇸 New York, New York, United States

Diabetes & Endocrinology Consultants, PC; 🇺🇸 Morehead City, North Carolina, United States

Carolina Ear Nose and Throat Clinic; 🇺🇸 Orangeburg, South Carolina, United States

Stonesifer Endocrine Care & Clinical Research Inc., PS; 🇺🇸 Federal Way, Washington, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States