NCT01509209

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2011

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, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

January 10, 2012

Last Update Submit

May 22, 2013

Conditions

Vasomotor Rhinitis

Keywords

vasomotorpseudoephedrinelevocetirizine

Outcome Measures

Primary Outcomes (1)

  • TVRSS(Total Vasomotor Rhinitis Symptom Score)

    the change from baseline in TVRSS

    2week

Secondary Outcomes (1)

  • TVRSS, VRSS

    1week or 2 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Pseudoephedrine / Levocetirizine

Cossac L

EXPERIMENTAL

Pseudoephedrine 120mg + Levocetirizine 2.5mg

Drug: Pseudoephedrine / Levocetirizine

Interventions

Pseudoephedrine / LevocetirizineDRUG

tablet, BID everyday

Also known as: Cossac L
Cossac LPlacebo

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of vasomotor rhinitis

You may not qualify if:

  • Significant concomitant medical condition
  • Use corticosteroids or other allergy medications during the study
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ear, nose and throat, Boramae Hospital

Dongjak, Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Vasomotor

Interventions

Pseudoephedrinelevocetirizine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • Kyungmi Park, Ph.D.

    Hanmi Pharmaceutical Company Limited

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 12, 2012

Study Start

May 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

KR(1)