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XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

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ClinicalTrials.gov Identifier: NCT03441373
Recruitment Status : Completed
First Posted : February 21, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
PHARMENTERPRISES LLC

Brief 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.


Condition or disease Intervention/treatment Phase
Influenza Acute Respiratory Infection Drug: XC8 20 mg Drug: XC8 100 mg Drug: XC8 200 mg Drug: Placebo Phase 2 Phase 3

Detailed Description:

Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase III. Each of the parts included 3 periods: screening, treatment, follow-up.

In the first part of the study (Phase II), all eligible patients were randomized into 4 groups (groups A, B, C, and D) in a 1:1:1:1 ratio:

Group A - XC8 20 mg daily (40 patients); Group B - XC8 100 mg daily (40 patients); Group C - XC8 200 mg daily (40 patients); Group D - placebo (40 patients).

Interim analysis was planned after the end of the first part of the study (Phase II). Based on the results of the interim analysis, the most promising XC8 dose group was selected and the necessary set was calculated to compare this group with the placebo group by the primary endpoint in a pooled set using an adaptive design with type I error control.

In the second part of the study (Phase III), all eligible patients were randomized into 2 groups (groups C and D) in a 1:1 ratio:

Group C - XC8 200 mg daily (80 patients); Group D - placebo (80 Patients).

During the treatment period (5 days), patients received XC8 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasted for 9 days.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Assess Efficacy, Safety, Tolerability and Optimal Dose Ranging of XC8 in Doses 20, 100 and 200 mg Once Daily in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections (ARVI)
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: XC8 20 mg and Placebo (Group A)
XC8 20 mg orally. 2 tablets of XC8 10 mg +2 tablets of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period
Drug: XC8 20 mg
once daily during 5 days.
Other Name: Нistamine glutarimide

Experimental: XC8 100 mg and Placebo (Group B)

XC8 100 mg orally.

1 tablet of XC8 100 mg +2 tablets of Placebo 10 mg + 1 tablet of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period

Drug: XC8 100 mg
once daily during 5 days.
Other Name: Нistamine glutarimide

Experimental: XC8 200 mg and Placebo (Group C)
XC8 200 mg orally. 2 tablets of XC8 100 mg +2 tablets of Placebo 10 mg (in total 4 tablets) once daily during 5 days of treatment period.
Drug: XC8 200 mg
once daily during 5 days.
Other Name: Нistamine glutarimide

Placebo Comparator: Placebo (Group D)
Placebo orally.
Drug: XC8 20 mg
once daily during 5 days.
Other Name: Нistamine glutarimide

Drug: XC8 100 mg
once daily during 5 days.
Other Name: Нistamine glutarimide

Drug: XC8 200 mg
once daily during 5 days.
Other Name: Нistamine glutarimide

Drug: Placebo
once daily during 5 days.




Primary Outcome Measures :
  1. Time to sustained improvement in clinical symptoms [ Time Frame: up to Day 5 ]
    Severity Rating Scale for ARVI (<2 points, provided that there is ≤ 1 point for one symptom) with temperature normalization (<37°C) (estimated by Kaplan-Meier), established according to patient diaries.


Secondary Outcome Measures :
  1. Body temperature below 37°C without further elevation [ Time Frame: up to Day 8 ]
    Time to normalization of body temperature since the symptoms onset, measured in hours



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441373


Locations
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Russian Federation
Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
Izhevsk, Russian Federation, 426063
State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",
Kazan, Russian Federation, 420012
State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
Krasnodar, Russian Federation, 350063
Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2
Nizhny Novgorod, Russian Federation, 603022
Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",
Novosibirsk, Russian Federation, 630068
Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",
Novosibirsk, Russian Federation, 630099
; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital № 3"
Podolsk, Russian Federation, 142105
Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",
Rostov-on-Don, Russian Federation, 344000
State Budgetary Institution of Higher Professional Education "Ryazan State Medical University n.a. Pavlov" of the Ministry of Health of the Russian Federation, Clinical site - SBHI of Ryazan region "Clinical Hospital n.a. Semashko"
Ryazan', Russian Federation, 390026
ArsVite Severo-Zapad LLC
Saint Petersburg, Russian Federation, 194223
Federal State Budgetary institution "Diagnostic center with polyclinics" of the Administrative Department of the President of the Russian Federation
Saint Petersburg, Russian Federation, 197110
Federal State Budgetary Institution "Research institute of influenza" of the Ministry of Health of the Russian Federation
Saint Petersburg, Russian Federation, 197376
Saint Petersburg SHBI "City Clinical Hospital #40 of health resort administrative region"
Saint Petersburg, Russian Federation, 197706
Federal State Budgetary Institution Mordovia State Medical University n..a. N.P.Ogarev, Mordovia Republic SHBI "Republic Infectious Clinical Hospital"
Saransk, Russian Federation, 430024
State Budgetary Institution of Higher Professional Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
Tomsk, Russian Federation, , 634050
State Budgetary Institution of Higher Professional Education "Volgograd State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Infectious Regional Clinical Hospital № 1
Volgograd, Russian Federation, 400131
State Budgetary Institution of Higher Professional Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Yaroslavl region State Healthcare Institution Infectious Regional Clinical Hospital # 1
Yaroslavl, Russian Federation, 150000
State Budgetary Healthcare Institution (SBHI) of Yaroslavl region
Yaroslavl, Russian Federation, 150007
Sponsors and Collaborators
PHARMENTERPRISES LLC

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Responsible Party: PHARMENTERPRISES LLC
ClinicalTrials.gov Identifier: NCT03441373     History of Changes
Other Study ID Numbers: FLU-XC8-01
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Infection
Communicable Diseases
Respiratory Tract Infections
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Glutarimide
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Enzyme Inhibitors