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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03336619




Registration number
NCT03336619
Ethics application status
Date submitted
6/11/2017
Date registered
8/11/2017

Titles & IDs
Public title
A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
Scientific title
A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
Secondary ID [1] 0 0
RM08-3004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nitazoxanide
Treatment: Drugs - Placebo

Active comparator: Nitazoxanide - Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days

Placebo comparator: Placebo - Two Placebo tablets orally twice daily (b.i.d.) for 5 days


Treatment: Drugs: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days

Treatment: Drugs: Placebo
Placebo administered orally twice daily for five days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From First Dose to Symptom Response
Timepoint [1] 0 0
Up to 21 days
Secondary outcome [1] 0 0
Time From First Dose to Ability to Perform All Normal Activities
Timepoint [1] 0 0
Up to 21 days
Secondary outcome [2] 0 0
Number of Subjects Experiencing One or More Complications of Influenza
Timepoint [2] 0 0
Up to 21 days
Secondary outcome [3] 0 0
Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains
Timepoint [3] 0 0
Up to 21 days

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2019
Sample size
Target
Accrual to date
Final
1030
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Vanguard Study Site - Morayfield
Recruitment hospital [2] 0 0
Vanguard Study Site - Sherwood
Recruitment hospital [3] 0 0
Vanguard Study Site - Victoria Point
Recruitment postcode(s) [1] 0 0
4506 - Morayfield
Recruitment postcode(s) [2] 0 0
4075 - Sherwood
Recruitment postcode(s) [3] 0 0
4165 - Victoria Point
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
Puerto Rico
State/province [17] 0 0
Ponce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Romark Laboratories L.C.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jean-Francois Rossignol, M.D., Ph.D.
Address 0 0
Romark Laboratories L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03336619