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NCT03094416 · ClinicalTrials.gov registry record · Phase 4
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
A Phase 4 study, sponsored by IBSA Institut Biochimique.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT03094416: Completed Phase 4 study, sponsored by IBSA Institut Biochimique.
NCT03094416 is a Phase 4 study that has completed, run by IBSA Institut Biochimique. The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03094416, a Phase 4 study, has completed, sponsored by IBSA Institut Biochimique.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study 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.
Primary Outcome
Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline
Interventions
- DRUG levothyroxine sodium capsule
- DRUG Proton pump inhibitor (PPI)
- DRUG Levothyroxine Sodium (LT4) Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2020-06-15 |
| Phase | Phase 4 |
What the finished NCT03094416 record still lists
NCT03094416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which levothyroxine sodium capsule is the first listed.
NCT03094416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03094416 about?
NCT03094416 is a clinical study titled "Levothyroxine Sodium 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.
What is the current status of trial NCT03094416?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2018-07-30. Estimated completion is 2020-06-15.
What interventions are being tested in trial NCT03094416?
The interventions under investigation include: levothyroxine sodium capsule (DRUG), Proton pump inhibitor (PPI) (DRUG), Levothyroxine Sodium (LT4) Tablets (DRUG).
Who is sponsoring clinical trial NCT03094416?
This trial is sponsored by IBSA Institut Biochimique, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03094416's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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