A Phase 2/3 interventional study of XC8 20 mg and XC8 100 mg in Influenza and Acute Respiratory Infection, sponsored by PHARMENTERPRISES LLC. Completed at 18 sites in Russian Federation. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by PHARMENTERPRISES LLC · Phase 2/3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The patient will be deemed ineligible for the study meeting any of the following criteria:
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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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
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
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
Placebo orally.
Drug: XC8 20 mg · Drug: XC8 100 mg · Drug: XC8 200 mg · Drug: Placebo
once daily during 5 days.
Also known as: Нistamine glutarimide
once daily during 5 days.
Also known as: Нistamine glutarimide
once daily during 5 days.
Also known as: Нistamine glutarimide
once daily during 5 days.
Time to sustained improvement in clinical symptoms
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.
Time frame: up to Day 5
Body temperature below 37°C without further elevation
Time to normalization of body temperature since the symptoms onset, measured in hours
Time frame: up to Day 8
Plan to share: No
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