Perennial Allergic RhinitisPhase 2NCT00210015
A Study in Subjects With Perennial Allergic Rhinitis
A Phase 2 study testing INS37217 Nasal Spray in people with Perennial Allergic Rhinitis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- INS37217 Nasal Spray
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Apr 2003
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
- Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
- Have not started or had a change in immunotherapy regimen.
Who cannot join
- Have a physical obstruction in the nose.
- Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
- Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
- Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
- Have asthma of sufficient severity to require use of excluded medications.
- Have taken any medications excluded as listed in the protocol.
- Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
- Are a current smoker, recent smoker or past smoker as defined in the protocol.
About this study
Official title: A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis
The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- INS37217 Nasal Spray
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS37217 Nasal SprayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
total nasal symptom score
Secondary outcomes (9)
average total nasal symptom scores over various timepoints average individual symptom scores
global assessment of perennial allergic rhinitis symptoms
instantaneous assessment of symptoms
change from baseline in quality of life assessments
physical and anterior nasal exams
laboratory tests
ECG
vital signs
adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 630 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Schaberg, B.S.N., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210015
- Sponsor's protocol ID
- 07-105
- Status last verified
- Jan 2016
- First submitted
- 13 Sep 2005
- Last updated
- 25 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00210015
- Acronym / sponsor ID
- 07-105
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 21 Sep 2005 (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 was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
- Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
- Have not started or had a change in immunotherapy regimen.
Key exclusion criteria (8 listed)
- Have a physical obstruction in the nose.
- Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
- Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
- Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
- Have asthma of sufficient severity to require use of excluded medications.
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 |
|---|---|---|
| INS37217 Nasal Spray | Drug | – |
Primary outcome
total nasal symptom score
9 secondary outcomes
average total nasal symptom scores over various timepoints average individual symptom scores
global assessment of perennial allergic rhinitis symptoms
instantaneous assessment of symptoms
change from baseline in quality of life assessments
physical and anterior nasal exams
laboratory tests
ECG
vital signs
adverse events
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 25 Jan 2016.
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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.
Amy Schaberg, B.S.N. study director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INS37217 Nasal Spray in people with Perennial 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 8 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 25 Jan 2016. 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?
total nasal symptom score. 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 25 Jan 2016.