NCT01509209CompletedPhase 3
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
Hanmi Pharmaceutical Company Limited1 site in 1 country137 target enrollmentStarted: May 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- TVRSS(Total Vasomotor Rhinitis Symptom Score)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
placebo
Intervention: Pseudoephedrine / Levocetirizine (Drug)
Cossac L
Experimental
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Intervention: Pseudoephedrine / Levocetirizine (Drug)
Outcomes
Primary Outcomes
TVRSS(Total Vasomotor Rhinitis Symptom Score)
Time Frame: 2week
the change from baseline in TVRSS
Secondary Outcomes
- TVRSS, VRSS(1week or 2 week)
Investigators
Study Sites (1)
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