NCT00407927

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
571

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

December 4, 2006

Last Update Submit

October 9, 2015

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change in nasal symptom scores

Secondary Outcomes (2)

  • Change in non-nasal symptom scores and quality of life scores

  • Standard safety assessments

Interventions

Epinastine Nasal SprayDRUG

Eligibility Criteria

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

You may qualify if:

  • A documented history of seasonal allergic rhinitis to mountain cedar pollen

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Allergy & Asthma Associates

Austin, Texas, 78731, United States

Location

Lovelace Scientific Resources, Inc.

Austin, Texas, 78759, United States

Location

Kerrville Research Associates

Kerrville, Texas, 78028, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy Asthma Research Institute

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

December 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

US(7)