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

May 22, 2013 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Dongjak, Seoul, Korea, Republic of, 156-707
        • ear, nose and throat, Boramae Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Names:
  • Cossac L
Experimental: Cossac L
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Names:
  • Cossac L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TVRSS(Total Vasomotor Rhinitis Symptom Score)
Time Frame: 2week
the change from baseline in TVRSS
2week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1week or 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Study Director: Kyungmi Park, Ph.D., Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-LCT-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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