NCT03722914

A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.

Detailed description

The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms. The study was designed to be randomized, double-blind, placebo-controlled.Subjects were randomly assigned to the benzonatate soft capsule group and the placebo group on a 1:1 basis。According to the regulatory requirements, 200 cases were planned to be included. Considering that poor efficacy of the placebo control group might lead to shedding, a 10% increase in shedding was achieved, and 220 cases were finally determined, with 110 cases in each group.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Benzonatate 200 mg	200 mg/pellet, 1pellet/time, 3times/day
DRUG	blank control 0mg	0 mg/pellet, 1pellet/time, 3times/day

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-12-31
• Completion: 2019-07-31
• First posted: 2018-10-29
• Last updated: 2018-10-29

Locations

14 sites across 1 country: China