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CompletedNCT01539304Updated Feb 28, 2012

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

A Phase 3 interventional study of CITUS Dry Syrup and Placebo in Perennial Allergic Rhinitis, sponsored by SamA Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 24 Months to 15 Years. Per ClinicalTrials.gov, last updated 2012-02-28.

Sponsored by SamA Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
24 Months to 15 Years
Sex
All
01

Study 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.

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Conditions studied

  • Perennial Allergic Rhinitis
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In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 245 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

SamA Pharmaceutical Co., Ltd is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Months to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
245 participants (actual)

Study arms

  • Experimental
    CITUS Dry Syrup

    Pranlukast dry syrup 10%

    Drug: CITUS Dry Syrup

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugCITUS Dry Syrup

    Pranlukast 10% dry syrup, b.i.d.

  • DrugPlacebo

    Placebo dry syrup, b.i.d

06

What researchers measure

Primary outcomes

  1. 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 \[Score 0(best) to 3(worst)\].

    Time frame: 4 week treatment period (from baseline through the end of week 4)

Secondary outcomes

  1. Assessing improvement of symptom by physician

    Time frame: from baseline through the end of week 4

  2. Assessing improvement of symptom by patient

    Time frame: from baseline through the end of week 4

  3. Mean change of Individual NIS

    Time frame: from baseline through the end of week 4

  4. Ratio distribution of NIS at end of week 4

    Percentage of each NIS score.

    Time frame: from baseline through the end of week 4

  5. Cure rate

    Time frame: from baseline through the end of week 4

  6. Cure rate for each symptom

    Time frame: from baseline through the end of week 4

  7. Use of rescue medication

    Time frame: from baseline through the end of week 4

  8. Change of Instantaneous NIS

    Time frame: from baseline through the end of week 4

07

Study locations

1 site
  • Seoul National University Hodpital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01539304
Lead sponsor
SamA Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Sep 2010
Primary completion
Aug 2011
Completion
Sep 2011
Last update
Feb 28, 2012

Study contacts

Young Yull Koh, MD
principal investigator · Seoul National University Hospital
Bok Yang Pyun, MD
principal investigator · Soonchunhyang University Hospital
Jae Won Oh, MD
principal investigator · Hanyang University
Yeong Ho Na, MD
principal investigator · Kyunghee University Medical Center
Soo Jong Hong, MD
principal investigator · Asan Medical Center
Hyun Hee Kim, MD
principal investigator · The Catholic University of Korea Bucheon St.Mary's Hospital
Dae Hyun Lim, MD
principal investigator · Inha University Hospital
Kang Mo Ahn, MD
principal investigator · Samsung Medical Center
Myung Hyun Sohn, MD
principal investigator · Severance Hospital
Jin Tack Kim, MD
principal investigator · The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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