Overview
XC8 in the Treatment of Patients With Acute Respiratory Viral Infection
Status:
Completed
Completed
Trial end date:
2017-02-09
2017-02-09
Target enrollment:
0
0
Participant gender:
All
All
Summary
A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PHARMENTERPRISES LLCTreatments:
Glutarimide
Histamine
Histamine phosphate
Criteria
Inclusion Criteria:1. Men and women aged 18 to 45 years (inclusively).
2. Clinically diagnosed influenza or other acute or moderate ARVI based on the patient's
body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the
following symptoms of intoxication: headache, general malaise, myalgia, pain in the
eyeballs.
3. Uncomplicated course of ARVI or influenza.
4. The onset of symptoms no more than 36h prior to the inclusion into the study.
5. Women of reproductive age (who are not in menopause and who have not undergone
surgical sterilization) and men who have sexual activity should use a reliable method
of contraception (acceptable methods of contraception in this study are: intrauterine
devices, oral contraceptives, contraceptive patch, long-acting injectable
contraceptives, a double barrier method (condom and diaphragm with spermicide)
throughout the study period.
6. Compliance with the treatment regimen, visits and laboratory examinations provided by
the protocol.
7. Signed Informant Consent Form.
Exclusion Criteria:
The patient will be deemed ineligible for the study meeting any of the following criteria:
1. Complicated course of influenza or ARVI (including the presence / development of
bacterial infection).
2. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and
interferon inducers, drugs that have immunomodulating action) or anti-infective agents
of systemic or local action.
3. Severe infection with signs of cardiovascular insufficiency development and other
manifestations of infectious-toxic shock, as well as with the presence of
neuroinfection syndrome (encephalic and meningoencephalic reactions,
polyradiculoneuritis, neuritis).
4. Signs of the development of viral pneumonia (the presence of two or more of the
following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of
percussion sound with a symmetrical evaluation of the upper and lower sections of the
lungs).
5. Infectious diseases during the last week before including into the study.
6. History of bronchial asthma.
7. History of increased convulsive activity.
8. Severe, decompensated or unstable somatic diseases (any diseases or conditions that
are life-threatening or may worsen the patient's prognosis, and make him/her
ineligible for the clinical study).
9. History of oncological diseases, HIV, tuberculosis.
10. Hypersensitivity to excipients of the XC8.
11. Diabetes mellitus, lactose intolerance, lactase deficiency.
12. Drug or alcohol abuse.
13. Participation in any other clinical trial in the last 90 days.
14. Pregnancy or lactation.
15. Military or prison populations.
16. Impossibility or inability to comply with the study procedures.
17. A member of the investigator's family or other person interested in the results of the
study
18. Abnormal laboratory results, which, according to the study doctor, interfere with the
patient's inclusion in the study.
19. History of renal insufficiency.
20. Only for patients participating in Phase III study: Patient involvement in the first
part of the study (Phase II) of FLU-XC8-01.
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