Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SamA Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01539304
First received: February 6, 2012
Last updated: February 26, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: CITUS Dry Syrup
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by SamA Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period [ Time Frame: 4 week treatment period (from baseline through the end of week 4) ] [ Designated as safety issue: No ]

    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)].



Secondary Outcome Measures:
  • Assessing improvement of symptom by physician [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
  • Assessing improvement of symptom by patient [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
  • Mean change of Individual NIS [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
  • Ratio distribution of NIS at end of week 4 [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
    Percentage of each NIS score.

  • Cure rate [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
  • Cure rate for each symptom [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]
  • Change of Instantaneous NIS [ Time Frame: from baseline through the end of week 4 ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CITUS Dry Syrup
Pranlukast dry syrup 10%
Drug: CITUS Dry Syrup
Pranlukast 10% dry syrup, b.i.d.
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo dry syrup, b.i.d

  Eligibility

Ages Eligible for Study:   24 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539304

Locations
Korea, Republic of
Seoul National University Hodpital
Seoul, Korea, Republic of
Sponsors and Collaborators
SamA Pharmaceutical Co., Ltd
Investigators
Principal Investigator: 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
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 The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
  More Information

No publications provided

Responsible Party: SamA Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01539304     History of Changes
Other Study ID Numbers: CITUS_P3
Study First Received: February 6, 2012
Last Updated: February 26, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014