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NCT01227421 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
A Phase 2 study, sponsored by Romark Laboratories L.C..
- Completed
- Registry status
- Phase 2
- Development phase
- 624
- Enrollment target
NCT01227421: Completed Phase 2 study, sponsored by Romark Laboratories L.C..
NCT01227421 is a Phase 2 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 624 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (369% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227421, a Phase 2 study, has completed, sponsored by Romark Laboratories L.C..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 624 participants
- Enrollment target
Study Summary
This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities.
Primary Outcome
The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection
Interventions
- DRUG Placebo
- DRUG Nitazoxanide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 624 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT01227421 record still lists
NCT01227421 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (369% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01227421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227421 about?
NCT01227421 is a clinical study titled "Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza". This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the dur...
What is the current status of trial NCT01227421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 624 participants. The study started on 2010-12. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01227421?
The interventions under investigation include: Placebo (DRUG), Nitazoxanide (DRUG).
Who is sponsoring clinical trial NCT01227421?
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 NCT01227421's enrollment target sits among peer trials
624 52nd of 2000 higher than 1,949 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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