Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Ve... | NCT01509209

Studies
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

NCT01509209

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

May 23, 2013Estimated

Enrollment

137Actual

Phase

Phase 3

Conditions

Vasomotor Rhinitis

Interventions

Pseudoephedrine / Levocetirizine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jan 10, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2013

Last Update Posted Date

May 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

randomized, double-blind, placebo-controlled, phase 3

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	placebo	Drug: Pseudoephedrine / Levocetirizine
Cossac L	Experimental	Pseudoephedrine 120mg + Levocetirizine 2.5mg	Drug: Pseudoephedrine / Levocetirizine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pseudoephedrine / Levocetirizine	Drug	tablet, BID everyday	Cossac L Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TVRSS(Total Vasomotor Rhinitis Symptom Score)	the change from baseline in TVRSS	2week

Secondary Outcomes

Measure	Description	Time Frame
TVRSS, VRSS	the change from baseline in TVRSS during 1st week and 2nd week the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week	1week or 2 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of vasomotor rhinitis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyungmi Park, Ph.D.	Hanmi Pharmaceutical Company Limited	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ear, nose and throat, Boramae Hospital		Dongjak	Seoul	156-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012223	Rhinitis, Vasomotor

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054199	Pseudoephedrine
C472067	levocetirizine

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided