Back to resultsEfficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Primary Purpose
Vasomotor Rhinitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pseudoephedrine / Levocetirizine
Sponsored by
About this trial
This is an interventional treatment trial for Vasomotor Rhinitis focused on measuring vasomotor, pseudoephedrine, levocetirizine
Eligibility Criteria
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
Sites / Locations
- ear, nose and throat, Boramae Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Cossac L
Arm Description
placebo
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Outcomes
Primary Outcome Measures
TVRSS(Total Vasomotor Rhinitis Symptom Score)
the change from baseline in TVRSS
Secondary Outcome Measures
TVRSS, VRSS
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
Full Information
NCT ID
NCT01509209
First Posted
January 10, 2012
Last Updated
May 22, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01509209
Brief Title
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Official Title
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis
Detailed Description
randomized, double-blind, placebo-controlled, phase 3
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Rhinitis
Keywords
vasomotor, pseudoephedrine, levocetirizine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Cossac L
Arm Type
Experimental
Arm Description
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine / Levocetirizine
Other Intervention Name(s)
Cossac L
Intervention Description
tablet, BID everyday
Primary Outcome Measure Information:
Title
TVRSS(Total Vasomotor Rhinitis Symptom Score)
Description
the change from baseline in TVRSS
Time Frame
2week
Secondary Outcome Measure Information:
Title
TVRSS, VRSS
Description
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
Time Frame
1week or 2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyungmi Park, Ph.D.
Organizational Affiliation
Hanmi Pharmaceutical Company Limited
Official's Role
Study Director
Facility Information:
Facility Name
ear, nose and throat, Boramae Hospital
City
Dongjak
State/Province
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
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