Back to resultsClinical Trial to Evaluate the Efficacy and Safety of CKD-342
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-342
Mometasone furoate
Levocabastine HCL
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility Criteria
Inclusion Criteria:
- male, female, Age: over 13 years(no age limiation in upper)
- subject who has experienced perennial allergic rhinitis for over 1 year
- subject who has identified allergens throughout the year within 12 months
- subject who has the symptoms of moderate to severe allergic rhinitis
- subject who can record the the patient diary during the clinical trial period
- subject who agreed to keep the same environment during the clinical trial period
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
- AST, ALT>2times the upper limit of normal at screening
- Serum creatinine >1.5times the upper limit of normal 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Treatment
Control 1
Control 2
Arm Description
CKD-342
Mometasone furoate
Levocabastine HCL
Outcomes
Primary Outcome Measures
change in rTNSS from baseline
Secondary Outcome Measures
change in rTNSS from baseline
change in AM rTNSS and PM rTNSS from baseline
Physician assessed overall nasal symptom from baseline
change from baseline in RQLQ
Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline
Full Information
NCT ID
NCT02498509
First Posted
July 5, 2015
Last Updated
December 22, 2016
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT02498509
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
459 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
CKD-342
Arm Title
Control 1
Arm Type
Active Comparator
Arm Description
Mometasone furoate
Arm Title
Control 2
Arm Type
Active Comparator
Arm Description
Levocabastine HCL
Intervention Type
Drug
Intervention Name(s)
CKD-342
Other Intervention Name(s)
investigational product
Intervention Description
treatment for 4 weeks after randomization
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate
Other Intervention Name(s)
investigational product
Intervention Description
treatment for 4 weeks after randomization
Intervention Type
Drug
Intervention Name(s)
Levocabastine HCL
Other Intervention Name(s)
investigational product
Intervention Description
treatment for 4 weeks after randomization
Primary Outcome Measure Information:
Title
change in rTNSS from baseline
Time Frame
up to week 4
Secondary Outcome Measure Information:
Title
change in rTNSS from baseline
Time Frame
up to week 2
Title
change in AM rTNSS and PM rTNSS from baseline
Time Frame
2 weeks and 4 weeks after the baseline assessment
Title
Physician assessed overall nasal symptom from baseline
Time Frame
2 weeks and 4 weeks after the basline assessment
Title
change from baseline in RQLQ
Time Frame
2 weeks and 4 weeks after the baseline assessment
Title
Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline
Time Frame
2 weeks and 4 weeks after the basline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male, female, Age: over 13 years(no age limiation in upper)
subject who has experienced perennial allergic rhinitis for over 1 year
subject who has identified allergens throughout the year within 12 months
subject who has the symptoms of moderate to severe allergic rhinitis
subject who can record the the patient diary during the clinical trial period
subject who agreed to keep the same environment during the clinical trial period
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
AST, ALT>2times the upper limit of normal at screening
Serum creatinine >1.5times the upper limit of normal 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
Facility Information:
Facility Name
Samsung Medical Center
City
Irwon-dong
State/Province
Gangnam-gu, Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
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