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NCT03336619 · ClinicalTrials.gov registry record · Phase 3
A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
A Phase 3 study, sponsored by Romark Laboratories L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,030
- Enrollment target
NCT03336619: Completed Phase 3 study, sponsored by Romark Laboratories L.C..
NCT03336619 is a Phase 3 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 1,030 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03336619, a Phase 3 study, has completed, sponsored by Romark Laboratories L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,030 participants
- Enrollment target
Study Summary
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.
Primary Outcome
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usua
Interventions
- DRUG Placebo
- DRUG Nitazoxanide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,030 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2019-04-17 |
| Phase | Phase 3 |
What the finished NCT03336619 record still lists
NCT03336619 is an interventional study that assigns participants to a tested intervention. Its 1,030 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03336619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03336619 about?
NCT03336619 is a clinical study titled "A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza". Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.
What is the current status of trial NCT03336619?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,030 participants. The study started on 2018-01-17. Estimated completion is 2019-04-17.
What interventions are being tested in trial NCT03336619?
The interventions under investigation include: Placebo (DRUG), Nitazoxanide (DRUG).
Who is sponsoring clinical trial NCT03336619?
This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03336619's enrollment target sits among peer trials
1,030 288th of 2000 higher than 1,713 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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