Clinical Trial to Evaluate the Efficacy and Safety of CKD-342

Rhinitis, Allergic, Perennial Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02498509
• Other study ID #: 153PAR14017
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2015
• Last updated: December 22, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

Clinical Trial to Evaluate the Efficacy and Safety of CKD-342

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

1. male, female, Age: over 13 years(no age limiation in upper)

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:

1. Asthma

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• CKD-342
treatment for 4 weeks after randomization
• Mometasone furoate
treatment for 4 weeks after randomization
• Levocabastine HCL
treatment for 4 weeks after randomization

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Irwon-dong	Gangnam-gu, Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in rTNSS from baseline		up to week 4	No
Secondary	change in rTNSS from baseline		up to week 2	No
Secondary	change in AM rTNSS and PM rTNSS from baseline		2 weeks and 4 weeks after the baseline assessment	No
Secondary	Physician assessed overall nasal symptom from baseline		2 weeks and 4 weeks after the basline assessment	No
Secondary	change from baseline in RQLQ		2 weeks and 4 weeks after the baseline assessment	No
Secondary	Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline		2 weeks and 4 weeks after the basline assessment	No