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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 is a Phase 3 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 1,941 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01610245
The ClinicalTrials.gov registry entry for NCT01610245 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,941 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Romark Laboratories L.C., which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo Oral Capsule is the first listed.
NCT01610245 reports 0 study locations.
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.
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