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

SamA Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: CITUS Dry Syrup; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539304

CITUS_P3

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 24 months to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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245 participants in 2 patient groups, including a placebo group

CITUS Dry Syrup

Experimental group

Description:

Pranlukast dry syrup 10%

Treatment:

Drug: CITUS Dry Syrup

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo