Clinical Trials Logo
  1. Home
  2. Seasonal Allergic Rhinitis
  3. NCT00564421
  4. Details
NCT00564421 Clinical Trial

Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

Seasonal Allergic Rhinitis Clinical Trial

Official title:
A Phase 3 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Dose Safety and Efficacy Study of Epinastine Nasal Spray vs. Placebo in Subjects With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00564421
Other study ID # P08648
Secondary ID 033-103
Status Completed
Phase Phase 3
First received November 27, 2007
Last updated March 23, 2017
Start date December 18, 2007
Est. completion date February 14, 2008

Study information
Verified date March 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis

Recruitment information / eligibility
Status Completed
Enrollment 798
Est. completion date February 14, 2008
Est. primary completion date February 14, 2008
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen

Exclusion Criteria:

- Significant medical condition

- Significant nasal abnormality

- Significant cardiac condition

- Recent infection

- Use of other allergy medication during the study

- Use of asthma medication other than as-needed albuterol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• epinastine nasal spray, low concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Other:
• placebo nasal spray
2 sprays in each nostril, dosed twice a day
Drug:
• epinastine nasal spray, low concentration, high dose volume
2 sprays in each nostril, dosed twice a day
• epinastine nasal spray, high concentration, low dose volume
2 sprays in each nostril, dosed twice a day
• epinastine nasal spray, high concentration, high dose volume
2 sprays in each nostril, dosed twice a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in nasal symptom scores 14 days
Secondary Change in ocular symptom scores and quality of life scores 14 days
Secondary Standard safety assessments 14 days
See also
  Status Clinical Trial Phase
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT01171664 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects Phase 2
Completed NCT00784732 - A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00619827 - Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract Phase 1
Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
Completed NCT00637455 - Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel Phase 4
Completed NCT00963599 - Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) Phase 3
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT06126952 - Azelastine Allergen Chamber - Onset of Action Study Phase 2
Completed NCT02245360 - Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis Phase 3
Completed NCT01940146 - Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis Phase 2
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT03097432 - Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment N/A