Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Assess Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

Status: Completed
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Signing and dating of the IPP informed consent form by the patient.

• Women and men between the ages of 18 and 65 years, inclusive, at the time of signing the informed consent form.

• Clinical diagnosis of acute respiratory viral infection of the upper respiratory tract (ICD-10 code J00-J06) or acute bronchitis (J20, J21 according to ICD-10).

• Onset of disease symptoms no more than 3 days prior to screening.

• Presence of a patient with a dry unproductive cough.

• Frequency of cough episodes ≥10 in the past 24 h before the screening visit and randomization.

• Cough frequency rated by the patient as 3-4 on the daytime cough section and 2-4 on the nighttime cough section of the Daytime and Nighttime Cough Scales.

• Patient rating of cough severity on the DRS ≥ 4 points.

• No indication for therapy due to BHSA infection at the time of study inclusion: negative rapid test for Group A β-haemolytic streptococcus.

⁃ For women of preserved reproductive potential, a negative pregnancy test and agreement to use approved contraceptive methods for the duration of study participation, beginning at visit 0, and for 3 weeks after the end of the study; for men, agreement to use approved contraceptive methods throughout the study participation period and for 3 weeks after the end of the study.

Locations
Other Locations
Russian Federation
Ivanovo Kuvaev Clinical Hospital
Ivanovo
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Healthcare of the Russian Federation
Kirov
Unimed-C Jsc
Moscow
EosMED JSC
Saint Petersburg
OrKli Hospital LLC.
Saint Petersburg
Uromed LLC
Smolensk
Time Frame
Start Date: 2022-05-23
Completion Date: 2022-07-29
Participants
Target number of participants: 250
Treatments
Experimental: XC8, film-coated tablets, 10 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Valenta Pharm JSC

This content was sourced from clinicaltrials.gov