Seoul National University Hodpital
Seoul, South Korea
NCT Number: NCT01539304
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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Notify Me24 month–15 year
All sexes
Interventional
Phase 3
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pranlukast 10% dry syrup, b.i.d.
Placebo dry syrup, b.i.d
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)].
Time frame: from baseline through the end of week 4
Time frame: from baseline through the end of week 4
Time frame: from baseline through the end of week 4
Time frame: from baseline through the end of week 4
Percentage of each NIS score.
Time frame: from baseline through the end of week 4
Time frame: from baseline through the end of week 4
Time frame: from baseline through the end of week 4
Time frame: from baseline through the end of week 4
SamA Pharmaceutical Co., Ltd
Industry
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
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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