Trial · NCT01227421
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT01227421, Phase 2, Phase 3, Completed, Romark Laboratories L.C.; results first posted 2014-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza. Trials, record NCT01227421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227421
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
- NCT number
- NCT01227421
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 624 participants, actual
- Lead sponsor
- Romark Laboratories L.C.
- Conditions
- Influenza
- Interventions
- Nitazoxanide, Nitazoxanide, Placebo
- First posted
- 2010-10-25
- Last updated
- 2023-10-12
- Results first posted
- 2014-01-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects | Up to 28 days | 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 |
| Secondary | Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | at least 28 days | Time in hours (Median and Interquartile range) |
| Secondary | Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline | 7 days | Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50) |
| Secondary | Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline | 7 days | Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies |
| Secondary | Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50) | 28 days | Median time in hours |
| Secondary | Time to Return to Normal Daily Activities | 28 days | Time in hours as reported by patient |
| Secondary | Symptom Severity Score Hours | 28 days | Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms. |
| Secondary | Time Loss From Work | 28 days | Time loss from work |
| Secondary | Complications of Influenza | 28 days | Proportion of patients with a complication of influenza during the course of the study |
| Secondary | Influenza Antibody Response Titer Change: Influenza A 2009 H1N1 | 28 days | change in influenza antibody titer for Influenza A 2009 H1N1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects | Up to 28 days | 624 patients were enrolled based on inclusion/exclusion criteria. The primary efficacy analysis was conducted on the 257 patients with laboratory confirmed influenza. | Hours | MEDIAN |
| SECONDARY | Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | at least 28 days | 624 patients were enrolled based on inclusion/exclusion criteria. Secondary efficacy analyses were conducted on the 257 patients with laboratory confirmed influenza. | Hours | MEDIAN |
| SECONDARY | Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline | 7 days | Analysis conducted on 113 patients from intensive virologic follow up group with laboratory confirmed influenza | LOG10 Titer | MEAN |
| SECONDARY | Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline | 7 days | Analysis conducted on 113 patients from the intensive virologic follow up group with laboratory confirmed influenza | LOG10 RNA copies | MEAN |
| SECONDARY | Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50) | 28 days | Analysis performed on 107 patients from the intensive virologic follow up population with laboratory confirmed influenza | Hours | MEDIAN |
| SECONDARY | Time to Return to Normal Daily Activities | 28 days | Analysis conducted on 257 patients with laboratory confirmed influenza | Hours | MEDIAN |
| SECONDARY | Symptom Severity Score Hours | 28 days | Analysis conducted for 257 patients with laboratory confirmed influenza | symptom score *hour | MEAN |
| SECONDARY | Time Loss From Work | 28 days | Analysis conducted on 241 patients with laboratory confirmed influenza excluding those who are unemployed | days | MEAN |
| SECONDARY | Complications of Influenza | 28 days | All patients who received at least one dose of study medication | Participants | NUMBER |
| SECONDARY | Influenza Antibody Response Titer Change: Influenza A 2009 H1N1 | 28 days | Member of the intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1 | Fold change in antibody titer | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects | Nitazoxanide 300mg | 109.1 | Inter-Quartile Range 81.5 to 151.9 | Hours | |
| Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects | Placebo | 116.7 | Inter-Quartile Range 91.3 to 144.0 | Hours | |
| Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects | Nitazoxanide 600mg | 95.5 | Inter-Quartile Range 71.2 to 125.8 | Hours | |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Nitazoxanide 300mg | Nasal Congestion | 84 | Inter-Quartile Range 72 to 92 | Hours |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Placebo | Nasal Congestion | 81 | Inter-Quartile Range 67 to 92 | Hours |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Nitazoxanide 600mg | Nasal Congestion | 60 | Inter-Quartile Range 48 to 74 | Hours |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Nitazoxanide 300mg | Runny Nose | 48 | Inter-Quartile Range 37 to 82 | Hours |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Placebo | Runny Nose | 42 | Inter-Quartile Range 36 to 56 | Hours |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Nitazoxanide 600mg | Runny Nose | 43 | Inter-Quartile Range 36 to 51 | Hours |
| Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | Nitazoxanide 300mg | Sore Throat | 63 | Inter-Quartile Range 48 to 74 | Hours |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nitazoxanide 300mg | 201 | |
| Overall Study | STARTED | Placebo | 212 | |
| Overall Study | STARTED | Nitazoxanide 600mg | 211 | |
| Overall Study | COMPLETED | Nitazoxanide 300mg | 190 | |
| Overall Study | COMPLETED | Placebo | 194 | |
| Overall Study | COMPLETED | Nitazoxanide 600mg | 201 | |
| Overall Study | NOT COMPLETED | Nitazoxanide 300mg | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Nitazoxanide 600mg | 10 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chromaturia | Renal and urinary disorders | Nitazoxanide 300mg | 6 | 201 | 6 |
| other | Chromaturia | Renal and urinary disorders | Placebo | 0 | 212 | 0 |
| other | Chromaturia | Renal and urinary disorders | Nitazoxanide 600mg | 8 | 211 | 8 |
| other | Mild Diarrhea | Gastrointestinal disorders | Nitazoxanide 300mg | 4 | 201 | 4 |
| other | Mild Diarrhea | Gastrointestinal disorders | Placebo | 7 | 212 | 7 |
| other | Mild Diarrhea | Gastrointestinal disorders | Nitazoxanide 600mg | 17 | 211 | 17 |
| serious | moderate pneumonia | Respiratory, thoracic and mediastinal disorders | Nitazoxanide 300mg | 0 | 201 | 0 |
| serious | moderate pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 212 | 0 |
| serious | moderate pneumonia | Respiratory, thoracic and mediastinal disorders | Nitazoxanide 600mg | 1 | 211 | 1 |
| serious | respiratory syncytial virus type A | Respiratory, thoracic and mediastinal disorders | Nitazoxanide 300mg | 0 | 201 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nitazoxanide 300mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Nitazoxanide 600mg | ||
| Total, other adverse events | Nitazoxanide 300mg | 10 | 201 |
| Total, other adverse events | Placebo | 7 | 212 |
| Total, other adverse events | Nitazoxanide 600mg | 25 | 211 |
| Total, serious adverse events | Nitazoxanide 300mg | 0 | 201 |
| Total, serious adverse events | Placebo | 1 | 212 |
| Total, serious adverse events | Nitazoxanide 600mg | 1 | 211 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24852376 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01227421
GET https://conductscience.org/api/trials/v1/NCT01227421/results?page=2