Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
This study has been completed.
Sponsor:
Romark Laboratories L.C.
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT01227421
First received: October 21, 2010
Last updated: May 3, 2011
Last verified: May 2011
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Purpose
This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Drug: Nitazoxanide |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents With Acute Uncomplicated Influenza |
Resource links provided by NLM:
Further study details as provided by Romark Laboratories L.C.:
Primary Outcome Measures:
- Time to resolution of all clinical symptoms of influenza as reported by the subjects [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to resolution of each individual symptom of influenza [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 622 |
| Study Start Date: | December 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nitazoxanide
300 mg nitazoxanide twice daily with food for 5 days
|
Drug: Nitazoxanide
300 mg controlled release tablet twice daily with food for 5 days
Drug: Nitazoxanide
2 X 300 mg nitazoxanide tablet twice daily with food
|
|
Placebo Comparator: Placebo
placebo tablet twice daily with food for 5 days
|
Drug: Nitazoxanide
300 mg controlled release tablet twice daily with food for 5 days
|
|
Active Comparator: nitazoxanide
2X 300 mg controlled release tablet twice daily with food for five days
|
Drug: Nitazoxanide
2 X 300 mg nitazoxanide tablet twice daily with food
|
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA
- age 12 to 65 years
Presence of clinical signs, respiratory symptoms and constitutional symptoms compatible with influenza infection:
- fever,
- at least one of the following respiratory symptoms: cough, sore throat, nasal discharge, nasal congestion, sneezing.
- At least one of the following constitutional symptoms: headache, myalgia, seats, chills, fatigue of any severity (mild, moderate, severe)
- Confirmation of Influenza A or B infection in the local community
- Onset of illness no more than 48 hours before presentation. 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 patient experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
- willing and able to comply with protocol requirements and provide informed consent
EXCLUSION CRITERIA:
- severity of illness requiring or anticipated to require in-hospital care
High risk of complications from influenza as follows:
- persons with asthma or other chronic pulmonary diseases
- persons with hemodynamically significant cardiac disease
- persons who have immunosuppressive disorders or receiving immunosuppressive therapy
- persons infected with Human Immunodeficiency Virus (HIV)
- persons with sickle cell anemia or other hemoglobinopathies
- persons with diseases requiring long-term aspirin therapy
- persons with chronic renal dysfunction
- persons with liver disorders
- Persons with cancer
- Persons with chronic metabolic disease such as diabetes and inherited mitochondrial disorders
- Persons with neuromuscular disorders, seizure disorders, or cognitive dysfunction
- Residents of any age of nursing homes or long-term institutions.
- Females of child bearing age who are pregnant, breastfeeding or sexually active without birth control
- vaccination for influenza or H1N1 (Swine Flu) on or after August 1, 2010
- treatment with antiviral medication such as oseltamivir, zanamivir, amantadine, or rimantadine within 30 days of screening.
- Prior treatment with nitazoxanide within 30 days prior to screening.
- subjects with active respiratory allergies or expected to require anti-allergy medications during the study period.
- known sensitivity to nitazoxanide
- subjects unable to take oral medication
- subjects with chronic kidney or liver disease
- Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227421
Locations
| United States, New York | |
| Health Sciences Research Center | |
| Elmira, New York, United States, 14901 | |
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
| Study Director: | Jean-Francois Rossignol, M.D., Ph.D. | Romark Laboratories L.C. |
More Information
No publications provided
| Responsible Party: | Celine Rossignol, MS, Romark Laboratories, L.C. |
| ClinicalTrials.gov Identifier: | NCT01227421 History of Changes |
| Other Study ID Numbers: | RM08-3001 |
| Study First Received: | October 21, 2010 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Romark Laboratories L.C.:
|
influenza |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Nitazoxanide Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013