A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza

June 2, 2022 updated by: Romark Laboratories L.C.
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A multicenter, randomized, double-blind, placebo controlled trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1030

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Morayfield, Queensland, Australia, 4506
        • Vanguard Study Site
      • Sherwood, Queensland, Australia, 4075
        • Vanguard Study Site
      • Victoria Point, Queensland, Australia, 4165
        • Vanguard Study Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00780
        • Vanguard Study Site
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Vanguard Study Site
      • Birmingham, Alabama, United States, 35235
        • Vanguard Study Site
      • Birmingham, Alabama, United States, 35242
        • Vanguard Study Site
      • Hoover, Alabama, United States, 35216
        • Vanguard Study Site
      • Pelham, Alabama, United States, 35124
        • Vanguard Study Site
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Vanguard Study Site
      • Tolleson, Arizona, United States, 85353
        • Vanguard Study Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Vanguard Study Site
    • California
      • Anaheim, California, United States, 92805
        • Vanguard Study Site
      • Westminster, California, United States, 92683
        • Vanguard Study Site
    • Florida
      • Lauderdale Lakes, Florida, United States, 33319
        • Vanguard Study Site
      • Orlando, Florida, United States, 32806
        • Vanguard Study Site
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Vanguard Study Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Vanguard Study Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Vanguard Study Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Vanguard Study Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Vanguard Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Vanguard Study Site
      • Columbus, Ohio, United States, 43214
        • Vanguard Study Site
      • Dayton, Ohio, United States, 45424
        • Vanguard Study Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Vanguard Study Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Vanguard Study Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Vanguard Study Site
      • Smyrna, Tennessee, United States, 37167
        • Vanguard Study Site
    • Texas
      • Austin, Texas, United States, 78735
        • Vanguard Study Site
      • Carrollton, Texas, United States, 75010
        • Vanguard Study Site
      • Dallas, Texas, United States, 75204
        • Vanguard Study Site
      • Dallas, Texas, United States, 75230
        • Vanguard Study Site
      • Fort Worth, Texas, United States, 76107
        • Vanguard Study Site
      • Houston, Texas, United States, 77058
        • Vanguard Study Site
      • Pharr, Texas, United States, 78577
        • Vanguard Study Site
      • Plano, Texas, United States, 75024
        • Vanguard Study Site
      • Plano, Texas, United States, 75093
        • Vanguard Study Site
    • Utah
      • Saint George, Utah, United States, 84790
        • Vanguard Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects at least 12 years of age

  2. Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):

    1. oral temperature ≥99.4°F or ≥37.4°C (obtained in office or self- measured within 12 hours prior to screening - if self-measured, subjects must also have taken an antipyretic within 4 hours prior to screening), AND
    2. at least one of the following respiratory symptoms (cough, sore throat, nasal obstruction), AND
    3. one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness).

  3. Confirmation of influenza A or B infection in the local community by one of the following means:

    1. the institution's local laboratory,
    2. the local public health system,
    3. the national public health system, OR
    4. a laboratory of a recognized national or multinational influenza surveillance scheme.

  4. Onset of illness no more than 40 hours before enrollment in the trial.

    Note: Time of onset of illness is defined as either the earlier of:

    1. the time when the temperature was first measured as elevated, OR
    2. the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
  5. Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the patient diary.

Exclusion Criteria:

  1. Severity of illness requiring or anticipated to require in-hospital care.
  2. Moderate or severe persistent asthma.
  3. Cystic fibrosis in children.
  4. Stage III or IV (severe or very severe) chronic obstructive pulmonary disease (COPD).
  5. Class III or IV congestive heart failure (at least marked limitation of physical activity in which minimal ordinary activity results in fatigue, palpitation, dyspnea, or angina pain)
  6. Arrhythmia
  7. Immunosuppressive disorders or who are receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants)
  8. Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
  9. Persons with sickle cell anemia or other hemoglobinopathies
  10. Poorly controlled insulin-dependent diabetes mellitus (HBA1C > 8%)
  11. Residents of any age of nursing homes or other long-term care institutions
  12. Concurrent infection at the screening examination that requires systemic antimicrobial therapy.
  13. Females of childbearing potential who are either pregnant, breast-feeding or are sexually active without the use of birth control. Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post- treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.
  14. Receipt of any dose of NTZ, oseltamivir, zanamivir, peramivir, laninamivir, baloxavir, amantadine or rimantadine within 3 days prior to screening.
  15. Prior treatment with any investigational drug therapy within 30 days prior to screening.
  16. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
  17. Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets.
  18. Subjects unable to take oral medications.
  19. Presence of any pre-existing illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
  20. Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days
Other Names:
  • NTZ
  • NT-300
PLACEBO_COMPARATOR: Placebo
Two Placebo tablets orally twice daily (b.i.d.) for 5 days
Drug: Placebo
Placebo administered orally twice daily for five days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time From First Dose to Symptom Response
Time Frame: Up to 21 days
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usual health.
Up to 21 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time From First Dose to Ability to Perform All Normal Activities
Time Frame: Up to 21 days
Subjects completed a diary including rating ability to perform normal activities on a scale from 0 (able to perform no normal activities) to 10 (able to perform all normal activities) daily in the evening. The time from first dose to ability to perform all normal activities is the time in hours between the first dose of study medication and that time when the subject first reported a score of "10" (able to perform all normal activities) for two consecutive daily diary periods without use of symptom relief medication.
Up to 21 days
Number of Subjects Experiencing One or More Complications of Influenza
Time Frame: Up to 21 days
Complications of influenza infection included pneumonia, otitis media, bronchitis, sinusitis, worsening of pre-existing health conditions, systemic antibiotic use for infections secondary to influenza infection, hospitalization due to influenza or complications of influenza and death.
Up to 21 days
Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains
Time Frame: Up to 21 days
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 25 FLU-PRO symptoms (excluding gastrointestinal and eye symptoms) was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 25 symptom thresholds most closely associated with patient-reported usual health.
Up to 21 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Return to Usual Health
Time Frame: 21 days
Subjects completed the FLU-PRO questionnaire including global assessment questions daily in the evening. The time from first dose to ability to return to usual health is the time in hours from the first dose of study medication to the first time when the subject answered "Have you returned to your usual health?" with "yes" for two consecutive daily diary periods without the use of symptom relief medication.
21 days
Proportion of Diaries Misclassified by Novel Response Definition
Time Frame: 21 days
The proportion of patient diaries misclassified by the response definition used for the primary efficacy analysis compared to patient reported usual health. A diary was considered "misclassified" if the response definition predicted "responded" and the patient reported not being at usual health or if the response definition predicted "not responded" and the patient reported being at usual health.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Romark Laboratories L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RM08-3004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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