Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT01539304
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2012-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-26', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': "Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit).\n\nNIS : 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)\\]."}], 'secondaryOutcomes': [{'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', 'description': 'Percentage of each NIS score.'}, {'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'}]}, 'conditionsModule': {'conditions': ['Perennial Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged over 24 months and under 15 years.\n2. Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.\n3. NIS mean total score of 1-week in baseline should be over 4.0.\n\nExclusion Criteria:\n\n1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).\n2. Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.\n3. Patient who has rhinitis not caused by allergy.\n4. Acute or chronic sinusitis.\n5. Patient who has medical history of allergy in seasonal pollen during the trial.\n6. Patient who has had eyes or nose surgery within 3 months prior to the trial.\n7. Patient who has had eye or upper airway infection within 1 week prior to the treatment period.\n8. Beginning immunotherapy or dose of change within 1 month prior to the trial.\n9. Patient who has clinical history of sensitivity to allergic rhinitis medication.\n10. Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.\n11. Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.\n12. Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.\n13. For girl who had her first period, result of pregnancy test was positive.'}, 'identificationModule': {'nctId': 'NCT01539304', 'briefTitle': 'Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SamA Pharmaceutical Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CITUS_P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CITUS Dry Syrup', 'description': 'Pranlukast dry syrup 10%', 'interventionNames': ['Drug: CITUS Dry Syrup']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CITUS Dry Syrup', 'type': 'DRUG', 'description': 'Pranlukast 10% dry syrup, b.i.d.', 'armGroupLabels': ['CITUS Dry Syrup']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo dry syrup, b.i.d', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hodpital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Yull Koh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Bok Yang Pyun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'Jae Won Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Yeong Ho Na, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Medical Center'}, {'name': 'Soo Jong Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Hyun Hee Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Catholic University of Korea Bucheon St.Mary's Hospital"}, {'name': 'Dae Hyun Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}, {'name': 'Kang Mo Ahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Myung Hyun Sohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}, {'name': 'Jin Tack Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Catholic University of Korea, Uijeongbu ST. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SamA Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}