Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis |
|---|---|
| Condition | Vasomotor Rhinitis |
| Intervention | Drug: Pseudoephedrine / Levocetirizine |
| Phase | Phase 3 |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Responsible Party | Hanmi Pharmaceutical Company Limited |
| ClinicalTrials.gov Identifier | NCT01509209 |
| First Received | January 10, 2012 |
| Last Updated | May 22, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 10, 2012 |
|---|---|
| Last Updated Date | May 22, 2013 |
| Start Date | May 2011 |
| Estimated Primary Completion Date | April 2013 |
| Current Primary Outcome Measures | TVRSS(Total Vasomotor Rhinitis Symptom Score) [Time Frame: 2week] [Designated as safety issue: No]the change from baseline in TVRSS |
| Current Secondary Outcome Measures | TVRSS, VRSS [Time Frame: 1week or 2 week] [Designated as safety issue: No]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 |
Descriptive Information[ + expand ][ + ]
| 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 |
| 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 Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Vasomotor Rhinitis |
| Intervention | Drug: Pseudoephedrine / Levocetirizine tablet, BID everyday Other Names: Cossac L |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 137 |
| Estimated Completion Date | April 2013 |
| Estimated Primary Completion Date | April 2013 |
| 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 |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01509209 |
|---|---|
| Other Study ID Numbers | HM-LCT-301 |
| Has Data Monitoring Committee | No |
| Information Provided By | Hanmi Pharmaceutical Company Limited |
| Study Sponsor | Hanmi Pharmaceutical Company Limited |
| Collaborators | Not Provided |
| Investigators | Study Director: Kyungmi Park, Ph.D. Hanmi Pharmaceutical Company Limited |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| ear, nose and throat, Boramae Hospital | Dongjak, Seoul, Korea, Republic of, 156-707 |
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