Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Hypothyroidism;Postablative Clinical Trial

Official title:

An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094416
• Other study ID #: 13US-T404
• Status: Completed
• Phase: Phase 4
• Start date: July 30, 2018
• Est. completion date: June 15, 2020

Study information

• Verified date: April 2022
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism
• Hypothyroidism;Postablative

Intervention

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
• Proton pump inhibitor (PPI)
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) Tablets
during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion

Locations

Country	Name	City	State
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Stonesifer Endocrine Care & Clinical Research Inc., PS	Federal Way	Washington
United States	California Head and Neck Specialists	La Jolla	California
United States	Diabetes & Endocrinology Consultants, PC	Morehead City	North Carolina
United States	NYC Health + Hospitals/ Queens	New York	New York
United States	Carolina Ear Nose and Throat Clinic	Orangeburg	South Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Coastal Metabolic Research Centre	Ventura	California
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Creatine Phosphokinase (CPK)	Change in Serum Levels of creatine phosphokinase (CPK) from Baseline	baseline and 12 weeks
Other	Sex Hormone Binding Globulin (SHBG)	Change in Serum Levels of SHBG (sex hormone binding globuline) from Baseline	baseline and 12 weeks
Other	Ferritin	Change in Serum Levels of ferritin from Baseline	baseline and 12 weeks
Other	Angiotensin Converting Enzyme (ACE)	Change in Serum Levels of ACE (angiotensin converting enzyme) from Baseline	baseline and 12 weeks
Other	Triglycerides	Change in triglycerides levels from Baseline	baseline and 12 weeks
Other	Cholesterol, Total	Change in total cholesterol levels from Baseline	baseline and 12 weeks
Other	Low Density Lipoprotein (LDL)-Cholesterol	Change in low density lipoprotein (LDL)-cholesterol levels from baseline	baseline and 12 weeks
Other	High Density Lipoprotein (HDL)-Cholesterol	Change in High Density Lipoprotein (HDL)-cholesterol levels from baseline	baseline and 12 weeks
Other	Very Low Density Lipoprotein (VLDL)-Cholesterol	Change in Very Low Density Lipoprotein (VLDL)-cholesterol levels from baseline	baseline and 12 weeks
Primary	Thyroid Stimulating Hormone (TSH)	Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline	baseline and 12 weeks
Secondary	Free Thyroxine (FT4)	Change in Serum Levels of FT4 (free thyroxine) from Baseline	baseline and 12 weeks
Secondary	Total Thyroxine (TT4)	Change in Serum Levels of TT4 (total thyroxine) from Baseline	baseline and 12 weeks
Secondary	Free Triiodothyronine (FT3)	Change in Serum Levels of FT3 (free triiodothyronine) from Baseline	baseline and 12 weeks
Secondary	Total Triiodothyronine (TT3)	Change in Serum Levels of TT3 (total triiodothyronine) from Baseline	baseline and 12 weeks