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

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ClinicalTrials.gov Identifier: NCT02498509
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: CKD-342 Drug: Mometasone furoate Drug: Levocabastine HCL Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
CKD-342
Drug: CKD-342
treatment for 4 weeks after randomization
Other Name: investigational product

Active Comparator: Control 1
Mometasone furoate
Drug: Mometasone furoate
treatment for 4 weeks after randomization
Other Name: investigational product

Active Comparator: Control 2
Levocabastine HCL
Drug: Levocabastine HCL
treatment for 4 weeks after randomization
Other Name: investigational product




Primary Outcome Measures :
  1. change in rTNSS from baseline [ Time Frame: up to week 4 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498509


Locations
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Korea, Republic of
Samsung Medical Center
Irwon-dong, Gangnam-gu, Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02498509     History of Changes
Other Study ID Numbers: 153PAR14017
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: July 2015

Additional relevant MeSH terms:
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Levocabastine
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs