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Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis

NCT02296814 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2015-07-17

No results posted yet for this study

Summary

Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal and paranasal sinuses).

Conditions

  • Acute Rhinosinusitis

Interventions

DRUG

Sinusitis Hevert SL Tablet

1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets

DRUG

Placebo for Sinusitis Hevert SL Tablet

1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets

Sponsors & Collaborators

  • Hevert-Arzneimittel GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Andreas Michalsen, Prof Dr · Immanuel Krankenhaus Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

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 NCT02296814 on ClinicalTrials.gov