Allergic RhinitisPhase 3NCT01982916
Clinical Trial to Evaluate the Safety and Efficacy of AGR Tablet as a Treatment of Perennial Allergic Rhinitis in Korean
A Phase 3 study testing AGR tablet and Active Comparator in people with Allergic Rhinitis and Perennial Allergic Rhinitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 9 sites in South Korea.
Trial summary
The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis
- What is being tested?
- AGR tablet and Active Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Dec 2013to Jan 2015
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or Females no younger than 12 years.
- Patient with a history of perennial allergic rhinitis for at least an year.
- Patient with a positive prick test performed on the same day or within one year before the inclusion date.Patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis.
- Patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit.
- Patients able to attend the required number of visits.
- A normal ECG.
Who cannot join
- Patients with non-allergic rhinitis.
- Patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion.
- Known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs.
- Asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment.
- Patients receiving desensitization treatment for any perennial allergen at the inclusion time. However, inclusion of subject stopping this treatment during the study period was permitted.
- Failure to pass properly the washout period of the following period.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Inha University Hospital
Incheon, 402-751
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, 110-744
Severance Hospital
Seoul, 120-751
Kyung Hee University Medical Center
Seoul, 130-872
Samsung Medical Center
Seoul, 135-710
Seoul St. Mary's Hospital
Seoul, 137-701
Konkuk University Medical Center
Seoul, 143-729
SMG-SNU Boramae Medical Center
Seoul, 156-707
About this study
Official title: A 4 Week Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of AGR Tablet in the Treatment of Perennial Allergic Rhinitis in Korean : a Phase III Clinical Trial Bridging Study
The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.
- Being tested
- AGR tablet, Placebo (for AGR tablet and/or Active Comparator), Active Comparator
- Keywords
- Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis, PAR
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGR tabletDrug
Placebo (for AGR tablet and/or Active Comparator)Drug
Active ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| AGR & Placebo | Experimental | AGR tablet by qd and Placebo by bid for 4 weeks Receives: Drug: AGR tablet; Drug: Placebo (for AGR tablet and/or Active Comparator) |
| Placebo | Placebo comparator | Placebo by bid for 4 weeks Receives: Drug: Placebo (for AGR tablet and/or Active Comparator) |
| Active comparator | Active comparator | Active Comparator and Placebo by bid for 4 weeks Receives: Drug: Placebo (for AGR tablet and/or Active Comparator); Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 4NTSS(4 Nasal Total Symptoms score) from baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center, Samsung Medical Center, Kyunghee University Medical Center, Konkuk University Medical Center, Inha University Hospital, Seoul St. Mary's Hospital, Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Chae-Seo Rhee, M.D., Study chair, Seoul National University Bundang HospitalTae-Bin Won, M.D., Principal investigator, Seoul National University HospitalDae-Woo Kim, M.D., Principal investigator, SMG-SNU Boramae Medical CenterHyo-Yeol Kim, M.D., Principal investigator, Samsung Medical CenterSung-Wan Kim, M.D., Principal investigator, Kyunghee University Medical CenterJin-Kook Kim, M.D., Principal investigator, Konkuk University Medical CenterYoung-Hyo Kim, M.D., Principal investigator, Inha University HospitalSoo-Whan Kim, M.D., Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982916
- Sponsor's protocol ID
- AGR_P3
- Status last verified
- Mar 2018
- First submitted
- 7 Nov 2013
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Week Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of AGR Tablet in the Treatment of Perennial Allergic Rhinitis in Korean : a Phase III Clinical Trial Bridging Study
- ClinicalTrials.gov ID
- NCT01982916
- Acronym / sponsor ID
- AGR_P3
- Keywords
- Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis, PAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center, Samsung Medical Center, Kyunghee University Medical Center, Konkuk University Medical Center, Inha University Hospital, Seoul St. Mary's Hospital, Severance Hospital
- Study start
- Dec 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015
- First posted
- 13 Nov 2013 (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.
The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGR & Placebo | Experimental | Drug: AGR tablet, Drug: Placebo (for AGR tablet and/or Active Comparator)AGR tablet by qd and Placebo by bid for 4 weeks |
| Placebo | Placebo comparator | Drug: Placebo (for AGR tablet and/or Active Comparator)Placebo by bid for 4 weeks |
| Active comparator | Active comparator | Drug: Placebo (for AGR tablet and/or Active Comparator), Drug: Active ComparatorActive Comparator and Placebo by bid for 4 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Males or Females no younger than 12 years.
- Patient with a history of perennial allergic rhinitis for at least an year.
- Patient with a positive prick test performed on the same day or within one year before the inclusion date.Patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis.
- Patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit.
- Patients able to attend the required number of visits.
Key exclusion criteria (6 listed)
- Patients with non-allergic rhinitis.
- Patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion.
- Known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs.
- Asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment.
- Patients receiving desensitization treatment for any perennial allergen at the inclusion time. However, inclusion of subject stopping this treatment during the study period was permitted.
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 |
|---|---|---|
| AGR tablet | Drug | AGR & Placebo |
| Placebo (for AGR tablet and/or Active Comparator) | Drug | AGR & Placebo, Active comparator, Placebo |
| Active Comparator | Drug | Active comparator |
Primary outcome
Change of 4NTSS(4 Nasal Total Symptoms score) from baseline
Time frame: 4 weeks
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 13 Mar 2018.
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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.
Chae-Seo Rhee, M.D. study chair
Seoul National University Bundang Hospital
Tae-Bin Won, M.D. principal investigator
Seoul National University Hospital
Dae-Woo Kim, M.D. principal investigator
SMG-SNU Boramae Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AGR tablet and Active Comparator in people with Allergic Rhinitis and Perennial Allergic Rhinitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 9 sites 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 6 inclusion and 6 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Change of 4NTSS(4 Nasal Total Symptoms score) from baseline (time frame: 4 weeks). 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 13 Mar 2018.