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

NCT ID: NCT01539304

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CITUS Dry Syrup

Pranlukast dry syrup 10%

Group Type EXPERIMENTAL

CITUS Dry Syrup

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo dry syrup, b.i.d

Interventions

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CITUS Dry Syrup

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

Intervention Type DRUG

Placebo

Placebo dry syrup, b.i.d

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

24 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SamA Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Yull Koh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Bok Yang Pyun, MD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Jae Won Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Yeong Ho Na, MD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Soo Jong Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Hyun Hee Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea Bucheon St.Mary's Hospital

Dae Hyun Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Kang Mo Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Myung Hyun Sohn, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Jin Tack Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Locations

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Seoul National University Hodpital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CITUS_P3

Identifier Type: -

Identifier Source: org_study_id