Rhinitis, Allergic, PerennialPhase 3NCT02498509
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
A Phase 3 study testing CKD-342, Mometasone furoate and Levocabastine HCL in people with Rhinitis, Allergic, Perennial, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342 Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- CKD-342, Mometasone furoate and Levocabastine HCL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to May 2016
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- male, female, Age: over 13 years(no age limiation in upper)
- subject who has experienced perennial allergic rhinitis for over 1 year
- subject who has identified allergens throughout the year within 12 months
- subject who has the symptoms of moderate to severe allergic rhinitis
- subject who can record the the patient diary during the clinical trial period
- subject who agreed to keep the same environment during the clinical trial period
Who cannot join
- Asthma
- Previous medical history at screening (Nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis)
- Patients with untreated localized infection in nasal mucosa
- Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable
- Patients with abnormal following laboratory test results at screening
- AST, ALT>2times the upper limit of normal at screening
Show all 17Show fewer
- Serum creatinine >1.5times the upper limit of normal at screening
- Previous history of acute or severe chronic sinusitis within 30 days at screening
- The continue use of drugs that may affect the efficacy of the Investigational product
- Start the immunotherapy or a change of doge within 1 month, at screening
- If you have glaucoma or cataracts, herpes simplex, or around the eyes
- Chronic obstructive pulmonary disease (COPD)
- history of hypersensitivity reactions and for treaties or major components of the IP
- Pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods
- Alcohol or illegal drug abuse or dependence in patients
- participation in any investigational or maketed drug within 4weeks preceding the screening visit
- Patients that can not be participating in a clinical trial by investigator's discretion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Irwon-dong, Gangnam-gu, Seoul, 135-710
About this study
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Concomitant Mometasone Furoate and Levocabastine HCl in Perennial Allergic Rhinitis Patients
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
Read the detailed description
A Randomized, Double-blind, Active-controlled, Multicenter phase 3 Clinical trial to evaluate the Efficacy and Safety of Concomitant Mometasone furoate and Levocabastine HCl in Perennial Allergic Rhinitis patients
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- CKD-342, Mometasone furoate, Levocabastine HCL
- 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.
CKD-342Drug
Also called investigational product
treatment for 4 weeks after randomization
Mometasone furoateDrug
Also called investigational product
treatment for 4 weeks after randomization
Levocabastine HCLDrug
Also called investigational product
treatment for 4 weeks after randomization
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | CKD-342 Receives: Drug: CKD-342 |
| Control 1 | Active comparator | Mometasone furoate Receives: Drug: Mometasone furoate |
| Control 2 | Active comparator | Levocabastine HCL Receives: Drug: Levocabastine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in rTNSS from baseline
Measured: up to week 4
Secondary outcomes (5)
change in rTNSS from baseline
Measured: up to week 2
change in AM rTNSS and PM rTNSS from baseline
Measured: 2 weeks and 4 weeks after the baseline assessment
Physician assessed overall nasal symptom from baseline
Measured: 2 weeks and 4 weeks after the basline assessment
change from baseline in RQLQ
Measured: 2 weeks and 4 weeks after the baseline assessment
Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline
Measured: 2 weeks and 4 weeks after the basline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 459 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498509
- Sponsor's protocol ID
- 153PAR14017
- Status last verified
- Jul 2015
- First submitted
- 5 Jul 2015
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Concomitant Mometasone Furoate and Levocabastine HCl in Perennial Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT02498509
- Acronym / sponsor ID
- 153PAR14017
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Jul 2015 (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.
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
Detailed description
A Randomized, Double-blind, Active-controlled, Multicenter phase 3 Clinical trial to evaluate the Efficacy and Safety of Concomitant Mometasone furoate and Levocabastine HCl in Perennial Allergic Rhinitis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: CKD-342CKD-342 |
| Control 1 | Active comparator | Drug: Mometasone furoateMometasone furoate |
| Control 2 | Active comparator | Drug: Levocabastine HCLLevocabastine HCL |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- male, female, Age: over 13 years(no age limiation in upper)
- subject who has experienced perennial allergic rhinitis for over 1 year
- subject who has identified allergens throughout the year within 12 months
- subject who has the symptoms of moderate to severe allergic rhinitis
- subject who can record the the patient diary during the clinical trial period
Key exclusion criteria (17 listed)
- Asthma
- Previous medical history at screening (Nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis)
- Patients with untreated localized infection in nasal mucosa
- Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable
- Patients with abnormal following laboratory test results at screening
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 |
|---|---|---|
| CKD-342Also: investigational producttreatment for 4 weeks after randomization | Drug | Treatment |
| Mometasone furoateAlso: investigational producttreatment for 4 weeks after randomization | Drug | Control 1 |
| Levocabastine HCLAlso: investigational producttreatment for 4 weeks after randomization | Drug | Control 2 |
Primary outcome
change in rTNSS from baseline
Time frame: up to week 4
5 secondary outcomes
change in rTNSS from baseline
Time frame: up to week 2
change in AM rTNSS and PM rTNSS from baseline
Time frame: 2 weeks and 4 weeks after the baseline assessment
Physician assessed overall nasal symptom from baseline
Time frame: 2 weeks and 4 weeks after the basline assessment
change from baseline in RQLQ
Time frame: 2 weeks and 4 weeks after the baseline assessment
Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline
Time frame: 2 weeks and 4 weeks after the basline assessment
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 26 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CKD-342, Mometasone furoate and Levocabastine HCL in people with Rhinitis, Allergic, Perennial, run by Chong Kun Dang Pharmaceutical 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 6 inclusion and 17 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 26 Dec 2016. 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. 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 in rTNSS from baseline (time frame: up to 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 26 Dec 2016.