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Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | CKD-342 |
|
| Control 1 | Active Comparator | Mometasone furoate |
|
| Control 2 | Active Comparator | Levocabastine HCL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-342 | Drug | treatment for 4 weeks after randomization |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in rTNSS from baseline | up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| change in rTNSS from baseline | up to week 2 | |
| change in AM rTNSS and PM rTNSS from baseline | 2 weeks and 4 weeks after the baseline assessment | |
| Physician assessed overall nasal symptom from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Irwon-dong | Gangnam-gu, Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| C047340 | levocabastine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Mometasone furoate | Drug | treatment for 4 weeks after randomization |
|
|
| Levocabastine HCL | Drug | treatment for 4 weeks after randomization |
|
|
| 2 weeks and 4 weeks after the basline assessment |
| change from baseline in RQLQ | 2 weeks and 4 weeks after the baseline assessment |
| Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline | 2 weeks and 4 weeks after the basline assessment |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |