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

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Mometasone furoate; Drug: CKD-342; Drug: Levocabastine HCL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02498509

153PAR14017

Details and patient eligibility

About

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

Full 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

Enrollment: 459 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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459 participants in 3 patient groups

Treatment

Experimental group

Description:

CKD-342

Treatment:

Drug: CKD-342

Control 1

Active Comparator group

Description:

Mometasone furoate

Treatment:

Drug: Mometasone furoate

Control 2

Active Comparator group

Description:

Levocabastine HCL

Treatment:

Drug: Levocabastine HCL