Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)
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ClinicalTrials.gov Identifier: NCT00564421 |
Recruitment Status :
Completed
First Posted : November 28, 2007
Last Update Posted : March 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Seasonal Allergic Rhinitis | Drug: epinastine nasal spray, low concentration, low dose volume Other: placebo nasal spray Drug: epinastine nasal spray, low concentration, high dose volume Drug: epinastine nasal spray, high concentration, low dose volume Drug: epinastine nasal spray, high concentration, high dose volume | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 798 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 18, 2007 |
Actual Primary Completion Date : | February 14, 2008 |
Actual Study Completion Date : | February 14, 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Epinastine low concentration:low dose volume |
Drug: epinastine nasal spray, low concentration, low dose volume
2 sprays in each nostril, dosed twice a day |
Experimental: Epinastine low concentration:high dose volume |
Drug: epinastine nasal spray, low concentration, high dose volume
2 sprays in each nostril, dosed twice a day |
Experimental: Epinastine high concentration:low dose volume |
Drug: epinastine nasal spray, high concentration, low dose volume
2 sprays in each nostril, dosed twice a day |
Experimental: Epinastine high concentration:high dose volume |
Drug: epinastine nasal spray, high concentration, high dose volume
2 sprays in each nostril, dosed twice a day |
Placebo Comparator: Placebo nasal spray |
Other: placebo nasal spray
2 sprays in each nostril, dosed twice a day
Other Name: Placebo |
- Change in nasal symptom scores [ Time Frame: 14 days ]
- Change in ocular symptom scores and quality of life scores [ Time Frame: 14 days ]
- Standard safety assessments [ Time Frame: 14 days ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564421
Study Director: | Donald Kellerman, PharmD | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00564421 |
Other Study ID Numbers: |
P08648 033-103 |
First Posted: | November 28, 2007 Key Record Dates |
Last Update Posted: | March 24, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php |
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Epinastine Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |