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Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough

NCT03837938 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2024-04-16

Study results available
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Summary

Primary objective:

To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8.

The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale".

Secondary objectives:

Treatment effect assessment in terms of the following efficacy and safety parameters:

* To assess the efficacy of Levopront® in comparison with Libexin® based on nighttime cough resolution rate by Day 8.
* Daytime and nighttime cough symptoms resolution according to "Six-point daytime and nighttime cough assessment scale" by Day 4.
* Change in severity and frequency of daytime and nighttime cough according to "Six-point daytime and nighttime cough assessment scale" on Day 4 and Day 8 from baseline on Day 1.
* Cough intensity change according to the visual-analogue scale on Day 4 and Day 8 from baseline on Day 1.
* Change of FEV1 on Day 8 from baseline values on Day 1.
* Rate of Adverse events (AE) and Serious Adverse Events (SAE) of the various severity according to subjective complaints, laboratory test results, physical examination, vital signs and spirometry

Conditions

Interventions

DRUG

Levopront® syrup 30 mg/5 ml

The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).

DRUG

Libexin®

The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Federico Saibene, MD · Dompé SpA Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-09
Primary Completion
2018-03-06
Completion
2018-07-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837938 on ClinicalTrials.gov