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

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: CKD-342; Drug: Levocabastine HCL; Drug: Mometasone furoate

• Registration Number: NCT02498509
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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 Timeline

• Study Start: 2015-05
• Status Verified: 2015-07
• Study First Submitted: 2015-07-05
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-15
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	CKD-342	CKD-342
Control 2	Levocabastine HCL	Levocabastine HCL
Control 1	Mometasone furoate	Mometasone furoate

Primary Outcome Measures

Name	Time	Method
change in rTNSS from baseline	up to week 4

Secondary Outcome Measures

Name	Time	Method
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
change from baseline in RQLQ	2 weeks and 4 weeks after the baseline assessment
Physician assessed overall nasal symptom from baseline	2 weeks and 4 weeks after the basline 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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Irwon-dong, Gangnam-gu, Seoul, Korea, Republic of