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OpenTrials
Completed

NCT Number: NCT01509209

Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Completed

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Key information

Conditions

Vasomotor Rhinitis Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Rhinitis Rhinitis, Vasomotor

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ear, nose and throat, Boramae Hospital

Dongjak, Seoul, 156-707, South Korea

About this study

randomized, double-blind, placebo-controlled, phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of vasomotor rhinitis

Exclusion criteria

  • Significant concomitant medical condition
  • Use corticosteroids or other allergy medications during the study
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason

Treatment and study plan

Pseudoephedrine / Levocetirizine

Drug

tablet, BID everyday

Other names: Cossac L

Primary outcomes

  1. TVRSS(Total Vasomotor Rhinitis Symptom Score)

    Time frame: 2week

    the change from baseline in TVRSS

Secondary outcomes

  1. TVRSS, VRSS

    Time frame: 1week or 2 week

    • the change from baseline in TVRSS during 1st week and 2nd week
    • the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2012
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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