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CompletedNCT00407927Updated Oct 12, 2015

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

A Phase 2 interventional study of Epinastine Nasal Spray in Seasonal Allergic Rhinitis, sponsored by Merck Sharp & Dohme LLC. Completed at 7 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
571
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 571 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
571 participants (actual)

Interventions

  • DrugEpinastine Nasal Spray
06

What researchers measure

Primary outcomes

  1. Change in nasal symptom scores

Secondary outcomes

  1. Change in non-nasal symptom scores and quality of life scores

  2. Standard safety assessments

07

Study locations

7 sites
  • Allergy & Asthma Associates
    Austin, Texas 78731, United States
  • Lovelace Scientific Resources, Inc.
    Austin, Texas 78759, United States
  • Kerrville Research Associates
    Kerrville, Texas 78028, United States
  • Central Texas Health Research
    New Braunfels, Texas 78130, United States
  • Biogenics Research Institute
    San Antonio, Texas 78229, United States
  • Sylvana Research Associates
    San Antonio, Texas 78229, United States
  • Allergy Asthma Research Institute
    Waco, Texas 76712, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00407927
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 5, 2006
Start date
Dec 2006
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Oct 12, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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