NCT02498509

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 26, 2016

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

July 5, 2015

Last Update Submit

December 22, 2016

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

  • change in rTNSS from baseline

    up to week 4

Secondary Outcomes (5)

  • 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

Study Arms (3)

Treatment

EXPERIMENTAL

CKD-342

Drug: CKD-342

Control 1

ACTIVE COMPARATOR

Mometasone furoate

Drug: Mometasone furoate

Control 2

ACTIVE COMPARATOR

Levocabastine HCL

Drug: Levocabastine HCL

Interventions

CKD-342DRUG

treatment for 4 weeks after randomization

Also known as: investigational product
Treatment
Mometasone furoateDRUG

treatment for 4 weeks after randomization

Also known as: investigational product
Control 1
Levocabastine HCLDRUG

treatment for 4 weeks after randomization

Also known as: investigational product
Control 2

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

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

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Mometasone Furoatelevocabastine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2015

First Posted

July 15, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

December 26, 2016

Record last verified: 2015-07

Locations

KR(1)