InfluenzaPhase 3NCT02612922
Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
A Phase 3 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 28 sites in 3 countries.
Trial summary
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 28 sitesin 3 countries
- Study dates
- Dec 2015to 4 Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 to 65 years
- Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):
- oral temperature of ≥100.4°F or ≥38°C (obtained in office or self-measured within 12 hours prior to screening - if self-measured, subject must also have taken an antipyretic within 4 hours prior to screening) AND
- at least one of the following respiratory symptoms (cough, sore throat, nasal obstruction), AND
- one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness).
- Confirmation of influenza A or B infection in the local community by one of the following means:
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- the institution's local laboratory,
- the local public health system,
- the national public health system, or
- a laboratory of a recognized national or multinational influenza surveillance scheme.
- 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:
- the time when the temperature was first measured as elevated, OR
- the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
- 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.
Who cannot join
- Severity of illness requiring or anticipated to require in-hospital care or subject defined as being at high risk of complications from influenza infection according to the Infectious Diseases Society of America (IDSA) guidelines for seasonal influenza in adults and children (Committee of Infectious Diseases (CID) 2009:48) or current Centers for Disease Control and Prevention (CDC) criteria. Current criteria for persons 12-65 years of age who are at risk of influenza complications include (list to be reviewed and updated as required prior to initiation of the study and at least monthly during the study):
- Persons with asthma or other chronic pulmonary diseases, such as cystic fibrosis in children or chronic obstructive pulmonary disease in adults.
- Persons with hemodynamically significant cardiac disease.
- Persons who have immunosuppressive disorders or who are receiving immunosuppressive therapy.
- Human Immunodeficiency Virus (HIV) infected persons.
- Persons with sickle cell anemia or other hemoglobinopathies.
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- Persons with diseases requiring long-term aspirin therapy, such as rheumatoid arthritis or Kawasaki disease.
- Persons with chronic renal dysfunction.
- Persons with liver disorders.
- Persons with active cancer.
- Persons with chronic metabolic disease, such as diabetes mellitus, inherited metabolic disorders and mitochondrial disorders.
- Persons with neuromuscular disorders, seizure disorders or cognitive dysfunction that may compromise the handling of respiratory secretions.
- Residents of any age of nursing homes or other long-term care institutions.
- Persons who are morbidly obese (Body Mass Index ≥40).
- American Indians.
- Alaskan natives.
- 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 intrauterine device (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 ovariectomy.
- Vaccination for seasonal influenza on or after August 1, 2015.
- Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, peramivir, amantadine or rimantadine within 30 days prior to screening.
- Prior treatment with any investigational drug therapy within 30 days prior to screening.
- Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
- Known sensitivity to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.
- Subjects unable to take oral medications.
- Subject has chronic kidney or liver disease (including Hepatitis A, B or C) or known impaired hepatic and/or renal function.
- Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.
- 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.
- Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States17 sites
Influence Study Site
Anaheim, California, 92805
Influence Study Site
Austin, Texas, 78735
Influence Study Site
Columbus, Georgia, 31904
Influence Study Site
Fresno, California, 93702
Influence Study Site
Hot Springs, Arkansas, 71913
Influence Study Site
Houston, Texas, 77058
Influence Study Site
Jackson, Tennessee, 38305
Influence Study Site
Kissimmee, Florida, 34744
Influence Study Site
Lansdale, Pennsylvania, 19446
Influence Study Site
Lauderdale Lakes, Florida, 33319
Influence Study Site
Lomita, California, 90717
Influence Study Site
Pharr, Texas, 78577
Influence Study Site
Plano, Texas, 75024
Influence Study Site
Rapid City, South Dakota, 57702
Influence Study Site
Saint Cloud, Florida, 34769
Influence Study Site
Savannah, Georgia, 31401
Influence Study Site
Waco, Texas, 76710
Australia9 sites
Influence Study Site
Berwick, Victoria, 3806
Influence Study Site
Brookvale, New South Wales, 2100
Influence Study Site
Browns Plains, Queensland, 4118
Influence Study Site
Castle Hill, New South Wales, 2154
Influence Study Site
Lynbrook, Victoria, 3957
Influence Study Site
Mosman, New South Wales, 2088
Influence Study Site
Rosebud, Victoria, 3939
Influence Study Site
Springfield, Queensland, 4300
Influence Study Site
Tarneit, Victoria, 3029
Puerto Rico2 sites
Influence Study Site
San Juan, 00912
Influence Study Site
San Juan, 00927
About this study
Official title: A Phase III Randomized Double-Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute uncomplicated influenza.
Read the detailed description
A multicenter randomized double-blind placebo controlled trial designed to evaluate efficacy and safety of NTZ 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza.
- Conditions
- Influenza
- Being tested
- Nitazoxanide, Placebo
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called NTZ, Alinia
Nitazoxanide 600 mg administered orally twice daily for five days
PlaceboDrug
Placebo administered orally twice daily for five days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Two Placebo tablets orally twice daily (b.i.d.) for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to alleviation of all clinical symptoms of influenza
Measured: Up to 28 days
Secondary outcomes (1)
Time to alleviation of each individual symptom of influenza
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion4 Sep 2016
- Study completion4 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Francois Rossignol, M.D., Ph.D., Study director, Romark Laboratories L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612922
- Sponsor's protocol ID
- RM08-3003
- Status last verified
- Apr 2018
- First submitted
- 20 Nov 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT02612922
- Acronym / sponsor ID
- RM08-3003
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 4 Sep 2016 (actual)
- Study completion
- 4 Sep 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute uncomplicated influenza.
Detailed description
A multicenter randomized double-blind placebo controlled trial designed to evaluate efficacy and safety of NTZ 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Active comparator | Drug: NitazoxanideTwo Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboTwo Placebo tablets orally twice daily (b.i.d.) for 5 days |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Age 12 to 65 years
- Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):
- Confirmation of influenza A or B infection in the local community by one of the following means:
- Onset of illness no more than 40 hours before enrollment in the trial.
- 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.
Key exclusion criteria (27 listed)
- Severity of illness requiring or anticipated to require in-hospital care or subject defined as being at high risk of complications from influenza infection according to the Infectious Diseases Society of America (IDSA) guidelines for seasonal influenza in adults and children (Committee of Infectious Diseases (CID) 2009:48) or current Centers for Disease Control and Prevention (CDC) criteria. Current criteria for persons 12-65 years of age who are at risk of influenza complications include (list to be reviewed and updated as required prior to initiation of the study and at least monthly during the study):
- 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 intrauterine device (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 ovariectomy.
- Vaccination for seasonal influenza on or after August 1, 2015.
- Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, peramivir, amantadine or rimantadine within 30 days prior to screening.
- Prior treatment with any investigational drug therapy within 30 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: NTZ, AliniaNitazoxanide 600 mg administered orally twice daily for five days | Drug | Nitazoxanide |
| PlaceboPlacebo administered orally twice daily for five days | Drug | Placebo |
Primary outcome
Time to alleviation of all clinical symptoms of influenza
Time frame: Up to 28 days
1 secondary outcome
Time to alleviation of each individual symptom of influenza
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Francois Rossignol, M.D., Ph.D. study director
Romark Laboratories L.C.
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to alleviation of all clinical symptoms of influenza (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.