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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01539304
Other study ID # CITUS_P3
Secondary ID
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


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
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