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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 is a Phase 2 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 624 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Nitazoxanide

Trial Details

FieldValue
Enrollment Target 624 participants
Start Date 2010-12
Est. Completion 2011-05
Phase Phase 2

Sponsor

Romark Laboratories L.C.

16 total trials

What the Registry Record Tells You About NCT01227421

The ClinicalTrials.gov registry entry for NCT01227421 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 624 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 2 interventions - of which Placebo is the first listed.

NCT01227421 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.