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Completed

NCT Number: NCT01539304

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

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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Key information

Age range

24 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hodpital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CITUS Dry Syrup

Drug

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

Placebo

Drug

Placebo dry syrup, b.i.d

Primary outcomes

  1. 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)

    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 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

    Time frame: from baseline through the end of week 4

    Percentage of each NIS score.

  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

Sponsors and collaborators

Lead sponsor

SamA Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 27, 2012
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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