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

NCT01539304 | Completed Phase 3

• 1 other identifier: CITUS_P3
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• Assessing improvement of symptom by physician

  from baseline through the end of week 4

• Assessing improvement of symptom by patient

  from baseline through the end of week 4

• Mean change of Individual NIS

  from baseline through the end of week 4

• Ratio distribution of NIS at end of week 4

  from baseline through the end of week 4

• Cure rate

  from baseline through the end of week 4

Study Arms (2)

CITUS Dry Syrup

EXPERIMENTAL

Pranlukast dry syrup 10%

Drug: CITUS Dry Syrup

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CITUS Dry Syrup DRUG

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

CITUS Dry Syrup

Placebo DRUG

Placebo dry syrup, b.i.d

Placebo

Eligibility Criteria

• Age: 24 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged over 24 months and under 15 years.
• Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.
• NIS mean total score of 1-week in baseline should be over 4.0.

You may not qualify if:

• Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).
• Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.
• Patient who has rhinitis not caused by allergy.
• Acute or chronic sinusitis.
• Patient who has medical history of allergy in seasonal pollen during the trial.
• Patient who has had eyes or nose surgery within 3 months prior to the trial.
• Patient who has had eye or upper airway infection within 1 week prior to the treatment period.
• Beginning immunotherapy or dose of change within 1 month prior to the trial.
• Patient who has clinical history of sensitivity to allergic rhinitis medication.
• Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.
• Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.
• Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.
• For girl who had her first period, result of pregnancy test was positive.

Sponsors & Collaborators

• SamA Pharmaceutical Co., Ltd: lead

Study Sites (1)

Seoul National University Hodpital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Young Yull Koh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Bok Yang Pyun, MD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Won Oh, MD

  Hanyang University Guri Hospital

  PRINCIPAL INVESTIGATOR

• Yeong Ho Na, MD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Soo Jong Hong, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Hyun Hee Kim, MD

  The Catholic University of Korea Bucheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Dae Hyun Lim, MD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Kang Mo Ahn, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Myung Hyun Sohn, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Jin Tack Kim, MD

  The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 27, 2012
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

KR (1)