Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
NCT ID: NCT02498509
Last Updated: 2016-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
459 participants
INTERVENTIONAL
2015-05-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
CKD-342
CKD-342
treatment for 4 weeks after randomization
Control 1
Mometasone furoate
Mometasone furoate
treatment for 4 weeks after randomization
Control 2
Levocabastine HCL
Levocabastine HCL
treatment for 4 weeks after randomization
Interventions
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CKD-342
treatment for 4 weeks after randomization
Mometasone furoate
treatment for 4 weeks after randomization
Levocabastine HCL
treatment for 4 weeks after randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. subject who has experienced perennial allergic rhinitis for over 1 year
3. subject who has identified allergens throughout the year within 12 months
4. subject who has the symptoms of moderate to severe allergic rhinitis
5. subject who can record the the patient diary during the clinical trial period
6. subject who agreed to keep the same environment during the clinical trial period
Exclusion Criteria
2. 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)
3. Patients with untreated localized infection in nasal mucosa
4. Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable
5. Patients with abnormal following laboratory test results at screening
* AST, ALT\>2times the upper limit of normal at screening
* Serum creatinine \>1.5times the upper limit of normal at screening
6. Previous history of acute or severe chronic sinusitis within 30 days at screening
7. The continue use of drugs that may affect the efficacy of the Investigational product
8. Start the immunotherapy or a change of doge within 1 month, at screening
9. If you have glaucoma or cataracts, herpes simplex, or around the eyes
10. Chronic obstructive pulmonary disease (COPD)
11. history of hypersensitivity reactions and for treaties or major components of the IP
12. Pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods
13. Alcohol or illegal drug abuse or dependence in patients
14. participation in any investigational or maketed drug within 4weeks preceding the screening visit
15. Patients that can not be participating in a clinical trial by investigator's discretion
13 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Samsung Medical Center
Irwon-dong, Gangnam-gu, Seoul, South Korea
Countries
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Other Identifiers
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153PAR14017
Identifier Type: -
Identifier Source: org_study_id