Perennial Allergic RhinitisPhase 3NCT01539304
Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
A Phase 3 study testing CITUS Dry Syrup in people with Perennial Allergic Rhinitis, run by SamA Pharmaceutical Co., Ltd at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 24 months to 15 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- CITUS Dry Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CITUS Dry Syrup, Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CITUS Dry SyrupDrug
Pranlukast 10% dry syrup, b.i.d.
PlaceboDrug
Placebo dry syrup, b.i.d
| Study group | Role | What they receive |
|---|---|---|
| CITUS Dry Syrup | Experimental | Pranlukast dry syrup 10% Receives: Drug: CITUS Dry Syrup |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: 4 week treatment period (from baseline through the end of week 4)
Secondary outcomes (8)
Assessing improvement of symptom by physician
Measured: from baseline through the end of week 4
Assessing improvement of symptom by patient
Measured: from baseline through the end of week 4
Mean change of Individual NIS
Measured: from baseline through the end of week 4
Ratio distribution of NIS at end of week 4
Percentage of each NIS score.
Measured: from baseline through the end of week 4
Cure rate
Measured: from baseline through the end of week 4
Cure rate for each symptom
Measured: from baseline through the end of week 4
Use of rescue medication
Measured: from baseline through the end of week 4
Change of Instantaneous NIS
Measured: from baseline through the end of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- SamA Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Yull Koh, MD, Principal investigator, Seoul National University HospitalBok Yang Pyun, MD, Principal investigator, Soonchunhyang University HospitalJae Won Oh, MD, Principal investigator, Hanyang University Guri HospitalYeong Ho Na, MD, Principal investigator, Kyunghee University Medical CenterSoo Jong Hong, MD, Principal investigator, Asan Medical CenterHyun Hee Kim, MD, Principal investigator, The Catholic University of Korea Bucheon St.Mary's HospitalDae Hyun Lim, MD, Principal investigator, Inha University HospitalKang Mo Ahn, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539304
- Sponsor's protocol ID
- CITUS_P3
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 28 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01539304
- Acronym / sponsor ID
- CITUS_P3
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- SamA Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CITUS Dry Syrup | Experimental | Drug: CITUS Dry SyrupPranlukast dry syrup 10% |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 24 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CITUS Dry SyrupPranlukast 10% dry syrup, b.i.d. | Drug | CITUS Dry Syrup |
| PlaceboPlacebo dry syrup, b.i.d | Drug | Placebo |
Primary outcome
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
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)].
8 secondary outcomes
Assessing improvement of symptom by physician
Time frame: from baseline through the end of week 4
Assessing improvement of symptom by patient
Time frame: from baseline through the end of week 4
Mean change of Individual NIS
Time frame: from baseline through the end of week 4
Ratio distribution of NIS at end of week 4
Time frame: from baseline through the end of week 4
Cure rate
Time frame: from baseline through the end of week 4
Cure rate for each symptom
Time frame: from baseline through the end of week 4
Use of rescue medication
Time frame: from baseline through the end of week 4
Change of Instantaneous NIS
Time frame: from baseline through the end of week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
Related trials for Perennial Allergic Rhinitis
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
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Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Dupilumab Effects Against Aeroallergen Challenge
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Yull Koh, MD principal investigator
Seoul National University Hospital
Bok Yang Pyun, MD principal investigator
Soonchunhyang University Hospital
Jae Won Oh, MD principal investigator
Hanyang University Guri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CITUS Dry Syrup in people with Perennial Allergic Rhinitis, run by SamA Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period (time frame: 4 week treatment period (from baseline through the end of week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.