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NCT01610245 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
A Phase 3 study, sponsored by Romark Laboratories L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,941
- Enrollment target
NCT01610245: Completed Phase 3 study, sponsored by Romark Laboratories L.C..
NCT01610245 is a Phase 3 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 1,941 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610245, a Phase 3 study, has completed, sponsored by Romark Laboratories L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,941 participants
- Enrollment target
Study Summary
This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.
Interventions
- DRUG Placebo Oral Capsule
- DRUG Oseltamivir
- DRUG Placebo Oral Tablet
- DRUG Nitazoxanide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,941 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-04-16 |
| Phase | Phase 3 |
What the finished NCT01610245 record still lists
NCT01610245 is an interventional study that assigns participants to a tested intervention. Its 1,941 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 (151% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo Oral Capsule is the first listed.
NCT01610245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610245 about?
NCT01610245 is a clinical study titled "Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza". This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy a...
What is the current status of trial NCT01610245?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,941 participants. The study started on 2013-03. Estimated completion is 2015-04-16.
What interventions are being tested in trial NCT01610245?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Oseltamivir (DRUG), Placebo Oral Tablet (DRUG), Nitazoxanide (DRUG).
Who is sponsoring clinical trial NCT01610245?
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 NCT01610245's enrollment target sits among peer trials
1,941 108th of 2000 higher than 1,893 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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