Allergic RhinitisPhase 2NCT01382654
Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
A Phase 2 study testing epinastine 0.1%, epinastine 0.1% with taste masking agent and epinastine 0.2% in people with Allergic Rhinitis, run by Merck Sharp & Dohme LLC.
Trial summary
The objectives of this study were to: Examine the tolerability of two formulations and two dose concentrations of epinastine. Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- epinastine 0.1%, epinastine 0.1% with taste masking agent and epinastine 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2006
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between ages 18-70
- history of SAR or PAR for 1 year
- mild symptoms
Who cannot join
- asthma or RAD
- respiratory tract infection within 14 days prior to screening
About this study
The objectives of this study were to:
- Examine the tolerability of two formulations and two dose concentrations of epinastine.
- Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study.
- Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.
- Conditions
- Allergic Rhinitis
- Being tested
- epinastine 0.1%, epinastine 0.1% with taste masking agent, epinastine 0.2%, epinastine 0.2% with taste masking agent, azelastine 0.1%
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinastine 0.1%Drug
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.1% with taste masking agentDrug
nasal spray 2 sprays to each nostril for a total for a 3 doses
epinastine 0.2%Drug
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2% with taste masking agentDrug
nasal spray 2 sprays to each nostril for a total of 3 doses
azelastine 0.1%Drug
nasal spray 2 sprays to each nostril for a total of 3 doses
| Study group | Role | What they receive |
|---|---|---|
| epinastine 0.1% | Experimental | nasal spray 2 sprays to each nostril for a total of 3 doses Receives: Drug: epinastine 0.1% |
| epinastine 0.1% with taste masking agent | Experimental | nasal spray 2 sprays to each nostril for a total of 3 doses Receives: Drug: epinastine 0.1% with taste masking agent |
| epinastine 0.2% | Experimental | nasal spray 2 sprays to each nostril for a total of 3 doses Receives: Drug: epinastine 0.2% |
| epinastine 0.2% with taste masking agent | Experimental | nasal spray 2 sprays to each nostril for a total of 3 doses Receives: Drug: epinastine 0.2% with taste masking agent |
| azelastine 0.1% | Active comparator | nasal spray 2 sprays in each nostril for a total of 3 doses Receives: Drug: azelastine 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)
Measured: 2 days
Secondary outcomes (1)
Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382654
- Sponsor's protocol ID
- 033-102
- Other IDs
- 033-102
- Status last verified
- Oct 2015
- First submitted
- 23 Jun 2011
- Last updated
- 2 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01382654
- Acronym / sponsor ID
- 033-102
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Jun 2011 (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 objectives of this study were to:
- Examine the tolerability of two formulations and two dose concentrations of epinastine.
- Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study.
- Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| epinastine 0.1% | Experimental | Drug: epinastine 0.1%nasal spray 2 sprays to each nostril for a total of 3 doses |
| epinastine 0.1% with taste masking agent | Experimental | Drug: epinastine 0.1% with taste masking agentnasal spray 2 sprays to each nostril for a total of 3 doses |
| epinastine 0.2% | Experimental | Drug: epinastine 0.2%nasal spray 2 sprays to each nostril for a total of 3 doses |
| epinastine 0.2% with taste masking agent | Experimental | Drug: epinastine 0.2% with taste masking agentnasal spray 2 sprays to each nostril for a total of 3 doses |
| azelastine 0.1% | Active comparator | Drug: azelastine 0.1%nasal spray 2 sprays in each nostril for a total of 3 doses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between ages 18-70
- history of SAR or PAR for 1 year
- mild symptoms
Key exclusion criteria (2 listed)
- asthma or RAD
- respiratory tract infection within 14 days prior to screening
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 0.1%nasal spray 2 sprays to each nostril for a total of 3 doses | Drug | epinastine 0.1% |
| epinastine 0.1% with taste masking agentnasal spray 2 sprays to each nostril for a total for a 3 doses | Drug | epinastine 0.1% with taste masking agent |
| epinastine 0.2%nasal spray 2 sprays to each nostril for a total of 3 doses | Drug | epinastine 0.2% |
| epinastine 0.2% with taste masking agentnasal spray 2 sprays to each nostril for a total of 3 doses | Drug | epinastine 0.2% with taste masking agent |
| azelastine 0.1%nasal spray 2 sprays to each nostril for a total of 3 doses | Drug | azelastine 0.1% |
Primary outcome
Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)
Time frame: 2 days
1 secondary outcome
Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine).
Time frame: 2 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 2 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epinastine 0.1%, epinastine 0.1% with taste masking agent and epinastine 0.2% in people with 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 3 inclusion and 2 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 2 Nov 2015. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ) (time frame: 2 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 2 Nov 2015.