A Study of Epinastine Nasal Spray in Subjects With Season... | NCT00407927

Studies
A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis

NCT00407927

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

571Actual

Phase

Phase 2

Conditions

Seasonal Allergic Rhinitis

Interventions

Epinastine Nasal Spray

Countries

United States

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

Oct 2015

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

Dec 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Dec 4, 2006

First Submission Date that Met QC Criteria

Dec 4, 2006

First Posted Date

Dec 5, 2006Estimated

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

Oct 9, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Description Module

Brief Summary

The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.

Detailed Description

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

571Actual

Name	Type	Description	Arm Group Labels	Other Names
Epinastine Nasal Spray	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in nasal symptom scores

Secondary Outcomes

Measure	Description	Time Frame
Change in non-nasal symptom scores and quality of life scores
Standard safety assessments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A documented history of seasonal allergic rhinitis to mountain cedar pollen

Exclusion Criteria:

Significant medical condition
Cardiovascular abnormality
Have a significant physical obstruction in the nose
Started or had a change in immunotherapy within the 30 days prior to

screening

Have nasal ulceration(s) or any active nasal bleeding
Require use of allergy medications during the study
Require use of asthma medications other than as needed albuterol

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergy & Asthma Associates		Austin	Texas	78731	United States
Lovelace Scientific Resources, Inc.

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided