Investigate the Safety/Tolerability and Efficacy of Bilas... | NCT01400828

Studies
Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis

NCT01400828

Sponsor

Yuhan Corporation

Status

Completed

Last Update Posted

Jul 10, 2014Estimated

Enrollment

239Actual

Phase

Phase 3

Conditions

Seasonal Allergic Rhinitis

Interventions

Bilastine
Desloratadine
Placebo

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

Jul 2014

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

Jun 2011

Primary Completion Date

Jun 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Jul 20, 2011

First Submission Date that Met QC Criteria

Jul 21, 2011

First Posted Date

Jul 22, 2011Estimated

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

Jul 8, 2014

Last Update Posted Date

Jul 10, 2014Estimated

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

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

239Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bilastine	Experimental	Intervention: Drug: Bilastine	Drug: Bilastine
Desloratadine	Active Comparator	Intervention: Drug: Desloratadine	Drug: Desloratadine
Placebo	Placebo Comparator	Intervention: Drug: Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bilastine	Drug	20 mg (encapsulated) tablets QD/14 days	Bilastine
Desloratadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC of TSS	The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment	14 days

Secondary Outcomes

Measure	Description	Time Frame
Change in TSS. Reflective symptoms	Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours.	14 days
Change in TSS. Instantaneous score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..

Exclusion Criteria:

Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
Patients were not allowed to take forbidden medications or not comply the study requirements.
Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
Pregnant or breast-feeding women were also excluded.
Women of childbearing potential had a pregnancy test done

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

ID	Term
C445659	bilastine
C121345	desloratadine