Seasonal Allergic RhinitisPhase 3NCT00564421
Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)
A Phase 3 study testing epinastine nasal spray, low concentration, low dose volume, epinastine nasal spray, low concentration, high dose volume and epinastine nasal spray, high concentration, low dose volume in people with Seasonal Allergic Rhinitis, run by Merck Sharp & Dohme LLC.
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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- epinastine nasal spray, low concentration, low dose volume, epinastine nasal spray, low concentration, high dose volume and epinastine nasal spray, high concentration, low dose volume
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 798 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2007to 14 Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen
Who cannot join
- 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
About this study
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
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
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- epinastine nasal spray, low concentration, low dose volume, placebo nasal spray, epinastine nasal spray, low concentration, high dose volume, epinastine nasal spray, high concentration, low dose volume, epinastine nasal spray, high concentration, high dose volume
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinastine nasal spray, low concentration, low dose volumeDrug
2 sprays in each nostril, dosed twice a day
placebo nasal sprayOther
Also called Placebo
2 sprays in each nostril, dosed twice a day
epinastine nasal spray, low concentration, high dose volumeDrug
2 sprays in each nostril, dosed twice a day
epinastine nasal spray, high concentration, low dose volumeDrug
2 sprays in each nostril, dosed twice a day
epinastine nasal spray, high concentration, high dose volumeDrug
2 sprays in each nostril, dosed twice a day
| Study group | Role | What they receive |
|---|---|---|
| Epinastine low concentration:low dose volume | Experimental | Not described Receives: Drug: epinastine nasal spray, low concentration, low dose volume |
| Epinastine low concentration:high dose volume | Experimental | Not described Receives: Drug: epinastine nasal spray, low concentration, high dose volume |
| Epinastine high concentration:low dose volume | Experimental | Not described Receives: Drug: epinastine nasal spray, high concentration, low dose volume |
| Epinastine high concentration:high dose volume | Experimental | Not described Receives: Drug: epinastine nasal spray, high concentration, high dose volume |
| Placebo nasal spray | Placebo comparator | Not described Receives: Other: placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal symptom scores
Measured: 14 days
Secondary outcomes (2)
Change in ocular symptom scores and quality of life scores
Measured: 14 days
Standard safety assessments
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study start18 Dec 2007
- Primary completion14 Feb 2008
- Study completion14 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Kellerman, PharmD, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564421
- Sponsor's protocol ID
- P08648
- Other IDs
- 033-103
- Status last verified
- Mar 2017
- First submitted
- 27 Nov 2007
- Last updated
- 24 Mar 2017
- Results posted
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00564421
- Acronym / sponsor ID
- P08648
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 798 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2007 (actual)
- Primary completion
- 14 Feb 2008 (actual)
- Study completion
- 14 Feb 2008 (actual)
- First posted
- 28 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Epinastine low concentration:low dose volume | Experimental | Drug: epinastine nasal spray, low concentration, low dose volume |
| Epinastine low concentration:high dose volume | Experimental | Drug: epinastine nasal spray, low concentration, high dose volume |
| Epinastine high concentration:low dose volume | Experimental | Drug: epinastine nasal spray, high concentration, low dose volume |
| Epinastine high concentration:high dose volume | Experimental | Drug: epinastine nasal spray, high concentration, high dose volume |
| Placebo nasal spray | Placebo comparator | Other: placebo nasal spray |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen
Key exclusion criteria (6 listed)
- Significant medical condition
- Significant nasal abnormality
- Significant cardiac condition
- Recent infection
- Use of other allergy medication during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epinastine nasal spray, low concentration, low dose volume2 sprays in each nostril, dosed twice a day | Drug | Epinastine low concentration:low dose volume |
| placebo nasal sprayAlso: Placebo2 sprays in each nostril, dosed twice a day | Other | Placebo nasal spray |
| epinastine nasal spray, low concentration, high dose volume2 sprays in each nostril, dosed twice a day | Drug | Epinastine low concentration:high dose volume |
| epinastine nasal spray, high concentration, low dose volume2 sprays in each nostril, dosed twice a day | Drug | Epinastine high concentration:low dose volume |
| epinastine nasal spray, high concentration, high dose volume2 sprays in each nostril, dosed twice a day | Drug | Epinastine high concentration:high dose volume |
Primary outcome
Change in nasal symptom scores
Time frame: 14 days
2 secondary outcomes
Change in ocular symptom scores and quality of life scores
Time frame: 14 days
Standard safety assessments
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Kellerman, PharmD study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epinastine nasal spray, low concentration, low dose volume, epinastine nasal spray, low concentration, high dose volume and epinastine nasal spray, high concentration, low dose volume in people with Seasonal Allergic Rhinitis, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nasal symptom scores (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.