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

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539304
• Other study ID #: CITUS_P3
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: February 26, 2012
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2012
• Source: SamA Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 15 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• CITUS Dry Syrup
Pranlukast 10% dry syrup, b.i.d.
• Placebo
Placebo dry syrup, b.i.d

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hodpital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SamA Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)].	4 week treatment period (from baseline through the end of week 4)	No
Secondary	Assessing improvement of symptom by physician		from baseline through the end of week 4	No
Secondary	Assessing improvement of symptom by patient		from baseline through the end of week 4	No
Secondary	Mean change of Individual NIS		from baseline through the end of week 4	No
Secondary	Ratio distribution of NIS at end of week 4	Percentage of each NIS score.	from baseline through the end of week 4	No
Secondary	Cure rate		from baseline through the end of week 4	No
Secondary	Cure rate for each symptom		from baseline through the end of week 4	No
Secondary	Use of rescue medication		from baseline through the end of week 4	No
Secondary	Change of Instantaneous NIS		from baseline through the end of week 4	No