Clinical trial NCT01539304: Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: SamA Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 245
Sex: ALL
Minimum age (years): 24
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Children aged over 24 months and under 15 years.
2. Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.
3. NIS mean total score of 1-week in baseline should be over 4.0.

Exclusion Criteria:

1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).
2. Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.
3. Patient who has rhinitis not caused by allergy.
4. Acute or chronic sinusitis.
5. Patient who has medical history of allergy in seasonal pollen during the trial.
6. Patient who has had eyes or nose surgery within 3 months prior to the trial.
7. Patient who has had eye or upper airway infection within 1 week prior to the treatment period.
8. Beginning immunotherapy or dose of change within 1 month prior to the trial.
9. Patient who has clinical history of sensitivity to allergic rhinitis medication.
10. Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.
11. Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.
12. Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.
13. For girl who had her first period, result of pregnancy test was positive.

Primary outcomes:
measure: Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
timeFrame: 4 week treatment period (from baseline through the end of week 4)
Secondary outcomes:
measure: Assessing improvement of symptom by physician
timeFrame: from baseline through the end of week 4
measure: Assessing improvement of symptom by patient
timeFrame: from baseline through the end of week 4
measure: Mean change of Individual NIS
timeFrame: from baseline through the end of week 4
measure: Ratio distribution of NIS at end of week 4
timeFrame: from baseline through the end of week 4
measure: Cure rate
timeFrame: from baseline through the end of week 4
measure: Cure rate for each symptom
timeFrame: from baseline through the end of week 4
measure: Use of rescue medication
timeFrame: from baseline through the end of week 4
measure: Change of Instantaneous NIS
timeFrame: from baseline through the end of week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hodpital
Study officials:
affiliation: Seoul National University Hospital
name: Young Yull Koh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Bok Yang Pyun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Jae Won Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Yeong Ho Na, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Soo Jong Hong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea Bucheon St.Mary's Hospital
name: Hyun Hee Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Dae Hyun Lim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Kang Mo Ahn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Myung Hyun Sohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
name: Jin Tack Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: