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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CITUS Dry Syrup | Experimental | Pranlukast dry syrup 10% |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CITUS Dry Syrup | Drug | Pranlukast 10% dry syrup, b.i.d. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period | Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit). NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale [Score 0(best) to 3(worst)]. | 4 week treatment period (from baseline through the end of week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing improvement of symptom by physician | from baseline through the end of week 4 | |
| Assessing improvement of symptom by patient | from baseline through the end of week 4 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Yull Koh, MD | Seoul National University Hospital | Principal Investigator |
| Bok Yang Pyun, MD | Soonchunhyang University Hospital | Principal Investigator |
| Jae Won Oh, MD | Hanyang University Guri Hospital | Principal Investigator |
| Yeong Ho Na, MD | Kyunghee University Medical Center | Principal Investigator |
| Soo Jong Hong, MD | Asan Medical Center | Principal Investigator |
| Hyun Hee Kim, MD | The Catholic University of Korea Bucheon St.Mary's Hospital | Principal Investigator |
| Dae Hyun Lim, MD | Inha University Hospital | Principal Investigator |
| Kang Mo Ahn, MD | Samsung Medical Center | Principal Investigator |
| Myung Hyun Sohn, MD | Severance Hospital | Principal Investigator |
| Jin Tack Kim, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hodpital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo |
| Drug |
Placebo dry syrup, b.i.d |
|
| Mean change of Individual NIS |
| from baseline through the end of week 4 |
| Ratio distribution of NIS at end of week 4 | Percentage of each NIS score. | from baseline through the end of week 4 |
| Cure rate | from baseline through the end of week 4 |
| Cure rate for each symptom | from baseline through the end of week 4 |
| Use of rescue medication | from baseline through the end of week 4 |
| Change of Instantaneous NIS | from baseline through the end of week 4 |
| The Catholic University of Korea, Uijeongbu St. Mary's Hospital |
| Principal Investigator |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |