MedTrace Logo

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

NCT01539304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2012-02-28

No results posted yet for this study

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.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

CITUS Dry Syrup

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

DRUG

Placebo

Placebo dry syrup, b.i.d

Sponsors & Collaborators

  • SamA Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Young Yull Koh, MD · Seoul National University Hospital

  • Bok Yang Pyun, MD · Soonchunhyang University Hospital

  • Jae Won Oh, MD · Hanyang University

  • Yeong Ho Na, MD · Kyunghee University Medical Center

  • Soo Jong Hong, MD · Asan Medical Center

  • Hyun Hee Kim, MD · The Catholic University of Korea Bucheon St.Mary's Hospital

  • Dae Hyun Lim, MD · Inha University Hospital

  • Kang Mo Ahn, MD · Samsung Medical Center

  • Myung Hyun Sohn, MD · Severance Hospital

  • Jin Tack Kim, MD · The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539304 on ClinicalTrials.gov