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Completed

NCT Number: NCT02498509

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

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

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Irwon-dong, Gangnam-gu, Seoul, 135-710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-342

Drug

treatment for 4 weeks after randomization

Other names: investigational product

Mometasone furoate

Drug

treatment for 4 weeks after randomization

Other names: investigational product

Levocabastine HCL

Drug

treatment for 4 weeks after randomization

Other names: investigational product

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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2015
Registry last updated
Dec 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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