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CompletedNCT03336619Updated Jun 28, 2022Results posted

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

A Phase 3 interventional study of Nitazoxanide and Placebo in Influenza, sponsored by Romark Laboratories L.C.. Completed at 38 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Romark Laboratories L.C. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,030
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

Read the detailed description

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

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,030 participants (actual)

Study arms

  • Active comparator
    Nitazoxanide

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

    Drug: Nitazoxanide

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugNitazoxanide

    Nitazoxanide 600 mg administered orally twice daily for five days

    Also known as: NTZ, NT-300

  • DrugPlacebo

    Placebo administered orally twice daily for five days

05

What researchers measure

Primary outcomes

  1. Time From First Dose to Symptom Response

    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.

    Time frame: Up to 21 days

Secondary outcomes

  1. Time From First Dose to Ability to Perform All Normal Activities

    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.

    Time frame: Up to 21 days

  2. Number of Subjects Experiencing One or More Complications of Influenza

    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.

    Time frame: Up to 21 days

  3. Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains

    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.

    Time frame: Up to 21 days

Other outcomes

  1. Time to Return to Usual Health

    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.

    Time frame: 21 days

  2. Proportion of Diaries Misclassified by Novel Response Definition

    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.

    Time frame: 21 days

06

Results

Posted Jun 28, 2022
Limitations and caveats
Limitations of this study include inability to establish meaningfulness of the novel primary endpoint and selection of patients for whom the benefit of antiviral therapy may be marginal (e.g., vaccinated, antibody-positive, and subjects with improving illness at Baseline).

Participant flow

Participant flow — Overall Study
MilestoneNitazoxanidePlacebo
Started515515
Positive for influenza by rt-pcr at baseline (intent-to-treat infected [itti] population)314306
Completed301290
Not completed214225
Withdrew: Completed study, but not positive for influenza by rt-pcr (not included in itti population)192204
Withdrew: Withdrawal by subject1716
Withdrew: Adverse event25
Withdrew: Physician decision30

Outcome measures

PrimaryTime From First Dose to Symptom Response

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.

Time frame:
Up to 21 days
Reported as:
Median · hours
Time From First Dose to Symptom Response
hoursNitazoxanidePlacebo
Time From First Dose to Symptom Response155.1 (103.7 to 266.3)153.9 (100.2 to 270.7)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon · p = 0.3765Analysis used a Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.
SecondaryTime From First Dose to Ability to Perform All Normal Activities

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.

Time frame:
Up to 21 days
Reported as:
Median · hours
Time From First Dose to Ability to Perform All Normal Activities
hoursNitazoxanidePlacebo
Time From First Dose to Ability to Perform All Normal Activities201.8 (126.6 to 362.7)200.8 (127.5 to 347.2)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon · p = 0.6331Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.
SecondaryNumber of Subjects Experiencing One or More Complications of Influenza

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.

Time frame:
Up to 21 days
Reported as:
Count of participants · Participants
Number of Subjects Experiencing One or More Complications of Influenza
ParticipantsNitazoxanidePlacebo
Number of Subjects Experiencing One or More Complications of Influenza5045
Statistical analysis
  • Nitazoxanide vs Placebo · Fisher Exact · p = 0.7382
SecondaryTime to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains

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.

Time frame:
Up to 21 days
Reported as:
Median · hours
Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains
hoursNitazoxanidePlacebo
Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains152.2 (100.8 to 248.9)151.7 (97.8 to 268.7)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon · p = 0.3236Gehan-Wilcoxon test stratified by time from symptom onset to enrollment and influenza vaccination status.
Other pre-specifiedTime to Return to Usual Health

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.

Time frame:
21 days
Reported as:
Median · hours
Time to Return to Usual Health
hoursNitazoxanidePlacebo
Time to Return to Usual Health176.6 (120.0 to 315.0)202.1 (126.6 to 322.1)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon · p = 0.0483Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.
Other pre-specifiedProportion of Diaries Misclassified by Novel Response Definition

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.

Time frame:
21 days
Reported as:
Number · diaries
Proportion of Diaries Misclassified by Novel Response Definition
diariesITTI Population
Proportion of Diaries Misclassified by Novel Response Definition0.20131
Post-hocCorrelation Coefficient for Sustained Response and Return to Usual Health

The correlation coefficient between sustained response and return to usual health was calculated for the pooled ITTI population (i.e., not by treatment group) as a measure of association between the primary endpoint response definition and its intended anchor, patient-reported return to usual health.

Time frame:
21 days
Reported as:
Number · correlation coefficient
Correlation Coefficient for Sustained Response and Return to Usual Health
correlation coefficientITTI Population
Correlation Coefficient for Sustained Response and Return to Usual Health0.51
Post-hocTime to Return to Usual Health, Placebo-Treated Subjects by Baseline Antibody Status

Survival analysis of Time to Return to Usual Health was repeated for subjects with laboratory-confirmed influenza (ITTI population) who were randomized to the placebo treatment group by whether the subjects had detectable anti-influenza antibodies at Baseline.

Time frame:
21 days
Reported as:
Median · hours
Time to Return to Usual Health, Placebo-Treated Subjects by Baseline Antibody Status
hoursPlacebo-Treated Subjects With Detectable Antibodies at BaselinePlacebo-Treated Subjects Without Detectable Antibodies at Baseline
Time to Return to Usual Health, Placebo-Treated Subjects by Baseline Antibody Status224.1 (128 to 359)261.5 (162 to 504)
Post-hocTime to Sustained Clinical Recovery

Alternative means of endpoint construction were pursued to strengthen the relationship between symptoms-based endpoint measures and subject global assessments of health. Time to Sustained Clinical Recovery is an endpoint based on evidence of meaningful within-subject change sustained for the duration of the study. Time to Sustained Clinical Recovery is the time in hours from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

Time frame:
21 days
Reported as:
Median · hours
Time to Sustained Clinical Recovery
hoursNitazoxanidePlacebo
Time to Sustained Clinical Recovery172.2 (81 to 346)176.4 (82 to 347)
Post-hocTime to Sustained Clinical Recovery by Antibody Status, Placebo-Treated Subjects

Alternative means of endpoint construction were pursued to strengthen the relationship between symptoms-based endpoint measures and subject global assessments of health. Time to Sustained Clinical Recovery is an endpoint based on evidence of meaningful within-subject change sustained for the duration of the study. Time to Sustained Clinical Recovery is the time in hours from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

Time frame:
21 days
Reported as:
Median · hours
Time to Sustained Clinical Recovery by Antibody Status, Placebo-Treated Subjects
hoursPlacebo-Treated Subjects With Detectable Antibodies at BaselinePlacebo-Treated Subjects Without Detectable Antibodies at Baseline
Time to Sustained Clinical Recovery by Antibody Status, Placebo-Treated Subjects141.0 (80 to 281)247.0 (104 to 457)
Post-hocTime to Sustained Clinical Recovery, Subjects Without Detectable Antibodies at Baseline

Alternative means of endpoint construction were pursued to strengthen the relationship between symptoms-based endpoint measures and subject global assessments of health. Time to Sustained Clinical Recovery is an endpoint based on evidence of meaningful within-subject change sustained for the duration of the study. Time to Sustained Clinical Recovery is the time in hours from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

Time frame:
21 days
Reported as:
Median · hours
Time to Sustained Clinical Recovery, Subjects Without Detectable Antibodies at Baseline
hoursNitazoxanidePlacebo
Time to Sustained Clinical Recovery, Subjects Without Detectable Antibodies at Baseline175.4 (84 to 321)247.0 (104 to 457)
Post-hocTime to Sustained Clinical Recovery, mITTI Population Without Detectable Antibodies at Baseline

Alternative means of endpoint construction were pursued to strengthen the relationship between symptoms-based endpoint measures and subject global assessments of health. Time to Sustained Clinical Recovery is an endpoint based on evidence of meaningful within-subject change sustained for the duration of the study. Time to Sustained Clinical Recovery is the time in hours from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

Time frame:
21 days
Reported as:
Median · hours
Time to Sustained Clinical Recovery, mITTI Population Without Detectable Antibodies at Baseline
hoursNitazoxanidePlacebo
Time to Sustained Clinical Recovery, mITTI Population Without Detectable Antibodies at Baseline170.3 (80 to 292)263.8 (121 to 462)

Adverse events

Collected over 21 dats. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nitazoxanide1/515 (0.2%)2/515 (0.4%)107/515 (20.8%)
Placebo0/515 (0%)1/515 (0.2%)36/515 (7%)
Most frequent serious events
Most frequent serious events
EventNitazoxanidePlacebo
Procedural pneumothoraxInjury, poisoning and procedural complications1/5150/515
TyphusInfections and infestations0/5151/515
Musculoskeletal painMusculoskeletal and connective tissue disorders1/5150/515
Most frequent other events
Most frequent other events
EventNitazoxanidePlacebo
ChromaturiaRenal and urinary disorders75/5155/515
DiarrhoeaGastrointestinal disorders34/51525/515
NauseaGastrointestinal disorders8/51513/515

Baseline characteristics

Age, Continuous
Age, Continuous(years)NitazoxanidePlaceboTotal
Mean35.0 ± 15.1136.3 ± 16.1435.6 ± 15.63
Sex: Female, Male
Sex: Female, Male(Participants)NitazoxanidePlaceboTotal
Female292285577
Male223230453
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)NitazoxanidePlaceboTotal
Black or African American4754101
Hispanic194194388
White256260516
Other18725
Weight
Weight(kg)NitazoxanidePlaceboTotal
Mean83.1 ± 24.2881.2 ± 22.5882.1 ± 23.45
BMI
BMI(kg/m^2)NitazoxanidePlaceboTotal
Mean29.6 ± 7.8529.1 ± 7.2729.3 ± 7.57
Smoking Status
Smoking Status(Participants)NitazoxanidePlaceboTotal
Current Smoker5349102
Past Smoker6469133
Never Smoked398397795
Time from Onset of Symptoms at First Study Drug Intake (ITTI)
Time from Onset of Symptoms at First Study Drug Intake (ITTI)(hours)NitazoxanidePlaceboTotal
Mean26.0 ± 9.026.5 ± 8.226.2 ± 8.6
Presence of Anti-Influenza Antibodies at Baseline
Presence of Anti-Influenza Antibodies at Baseline(Participants)NitazoxanidePlaceboTotal
Anti-Influenza Antibodies Detected at Baseline188181369
Anti-Influenza Antibodies Not Detected at Baseline109105214
07

Study locations

38 sites
  • Vanguard Study Site
    Alabaster, Alabama 35007, United States
  • Vanguard Study Site
    Birmingham, Alabama 35235, United States
  • Vanguard Study Site
    Birmingham, Alabama 35242, United States
  • Vanguard Study Site
    Hoover, Alabama 35216, United States
  • Vanguard Study Site
    Pelham, Alabama 35124, United States
  • Vanguard Study Site
    Goodyear, Arizona 85338, United States
  • Vanguard Study Site
    Tolleson, Arizona 85353, United States
  • Vanguard Study Site
    Hot Springs, Arkansas 71913, United States
  • Vanguard Study Site
    Anaheim, California 92805, United States
  • Vanguard Study Site
    Westminster, California 92683, United States
  • Vanguard Study Site
    Lauderdale Lakes, Florida 33319, United States
  • Vanguard Study Site
    Orlando, Florida 32806, United States
  • Vanguard Study Site
    Valparaiso, Indiana 46383, United States
  • Vanguard Study Site
    New Orleans, Louisiana 70124, United States
  • Vanguard Study Site
    Saint Louis, Missouri 63141, United States
  • Vanguard Study Site
    Missoula, Montana 59808, United States
  • Vanguard Study Site
    Brooklyn, New York 11229, United States
  • Vanguard Study Site
    Cincinnati, Ohio 45215, United States
  • Vanguard Study Site
    Columbus, Ohio 43214, United States
  • Vanguard Study Site
    Dayton, Ohio 45424, United States
  • Vanguard Study Site
    Medford, Oregon 97504, United States
  • Vanguard Study Site
    Rapid City, South Dakota 57702, United States
  • Vanguard Study Site
    Jackson, Tennessee 38305, United States
  • Vanguard Study Site
    Smyrna, Tennessee 37167, United States
  • Vanguard Study Site
    Austin, Texas 78735, United States
  • Vanguard Study Site
    Carrollton, Texas 75010, United States
  • Vanguard Study Site
    Dallas, Texas 75204, United States
  • Vanguard Study Site
    Dallas, Texas 75230, United States
  • Vanguard Study Site
    Fort Worth, Texas 76107, United States
  • Vanguard Study Site
    Houston, Texas 77058, United States
  • Vanguard Study Site
    Pharr, Texas 78577, United States
  • Vanguard Study Site
    Plano, Texas 75024, United States
  • Vanguard Study Site
    Plano, Texas 75093, United States
  • Vanguard Study Site
    Saint George, Utah 84790, United States
  • Vanguard Study Site
    Morayfield, Queensland 4506, Australia
  • Vanguard Study Site
    Sherwood, Queensland 4075, Australia
  • Vanguard Study Site
    Victoria Point, Queensland 4165, Australia
  • Vanguard Study Site
    Ponce, 00780, Puerto Rico
08

References and documents

Study documents

  • Study protocol · Jan 3, 2019
  • Statistical analysis plan · Jul 20, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03336619
Lead sponsor
Romark Laboratories L.C.
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Jan 17, 2018
Primary completion
Apr 17, 2019
Completion
Apr 17, 2019
Results posted
Jun 28, 2022
Last update
Jun 28, 2022

Study contacts

Jean-Francois Rossignol, M.D., Ph.D.
study director · Romark Laboratories L.C.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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