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

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

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: CKD-342; Drug: Mometasone furoate; Drug: Levocabastine HCL

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 Type: Interventional
• Enrollment (Anticipated): 459
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu, Seoul
    • Irwon-dong, Gangnam-gu, Seoul, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; CKD-342	Drug: CKD-342; treatment for 4 weeks after randomization; Other Names: investigational product
Active Comparator: Control 1; Mometasone furoate	Drug: Mometasone furoate; treatment for 4 weeks after randomization; Other Names: investigational product
Active Comparator: Control 2; Levocabastine HCL	Drug: Levocabastine HCL; treatment for 4 weeks after randomization; Other Names: investigational product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in rTNSS from baseline	up to week 4

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 5, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): December 26, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Mometasone Furoate; Levocabastine
• Other Study ID Numbers: 153PAR14017