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Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

NCT03794804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2019-08-22

No results posted yet for this study

Summary

This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.

Conditions

  • Common Cold

Interventions

DEVICE

ColdZyme

ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (\<1 %), calcium chloride, trometamol and menthol. ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.

DEVICE

ColdZyme Placebo

The placebo mouth spray solution has the following composition: ethanol (\<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.

Sponsors & Collaborators

  • Analyze & Realize

    collaborator NETWORK

  • Enzymatica AB

    lead INDUSTRY

Principal Investigators

  • Ralf Uebelhack, Prof. Dr. med. · analyze & realize GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2019-06-26
Completion
2019-06-26

Countries

  • Germany

Study Locations

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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 NCT03794804 on ClinicalTrials.gov