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CompletedNCT02498509Updated Dec 26, 2016

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

A Phase 3 interventional study of CKD-342 and Mometasone furoate in Rhinitis, Allergic, Perennial, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2016-12-26.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
459
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Rhinitis, Allergic, Perennial
03

In context

Rhinitis, Allergic, Perennial

186 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 8 are open to participants now.

This study's planned enrollment of 459 is above the median of 131 across 164 interventional studies indexed under Rhinitis, Allergic, Perennial.

Browse Rhinitis, Allergic, Perennial studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
459 participants (estimated)

Study arms

  • Experimental
    Treatment

    CKD-342

    Drug: CKD-342

  • Active comparator
    Control 1

    Mometasone furoate

    Drug: Mometasone furoate

  • Active comparator
    Control 2

    Levocabastine HCL

    Drug: Levocabastine HCL

Interventions

  • DrugCKD-342

    treatment for 4 weeks after randomization

    Also known as: investigational product

  • treatment for 4 weeks after randomization

    Also known as: investigational product

  • treatment for 4 weeks after randomization

    Also known as: investigational product

06

What researchers measure

Primary outcomes

  1. change in rTNSS from baseline

    Time frame: up to week 4

Secondary outcomes

  1. change in rTNSS from baseline

    Time frame: up to week 2

  2. change in AM rTNSS and PM rTNSS from baseline

    Time frame: 2 weeks and 4 weeks after the baseline assessment

  3. Physician assessed overall nasal symptom from baseline

    Time frame: 2 weeks and 4 weeks after the basline assessment

  4. change from baseline in RQLQ

    Time frame: 2 weeks and 4 weeks after the baseline assessment

  5. 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

07

Study locations

1 site
  • Samsung Medical Center
    Irwon-dong, Gangnam-gu, Seoul 135-710, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02498509
Responsible party
Sponsor
First posted
Jul 15, 2015
Start date
May 2015
Primary completion
Mar 2016
Completion
May 2016
Last update
Dec 26, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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