Rhinitis, Allergic, SeasonalPhase 2NCT00115089
7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
A Phase 2 study testing R926112 and Beclomethasone dipropionate in people with Rhinitis, Allergic, Seasonal, run by Rigel Pharmaceuticals.
Trial summary
This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- R926112 and Beclomethasone dipropionate
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Sep 2005
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must sign a written informed consent form and assent (if applicable) for study participation.
- Males and females, 12 years of age or older
- Subjects must have a history consistent with seasonal allergic rhinitis (SAR) during the fall pollen season for at least the previous 2 years.
- Subjects must be skin test positive to a relevant fall aeroallergen within the past 12 months with at least a moderate reaction as defined by at least a 5 mm wheal.
- Nasal exam to exclude significant swelling, bleeding, crusting, or polyps
- Subjects receiving immunotherapy must be on a stable maintenance regimen for at least 30 days before screening. Adjustments to the regimen following a brief period of missed injections or the normal reduction in dose due to a vaccine refill does not preclude participation.
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- Female subjects of childbearing potential must have negative urine tests for pregnancy at Visits 1 and 2.
- Female subjects of childbearing potential who are sexually active will be expected to use a medically recognized birth control method throughout the study: systemic contraceptive (oral, implant, injection, patch), diaphragm with intravaginal spermicide, cervical cap, vaginal ring, intrauterine device, or condom with spermicide. Females who are not sexually active will be admitted by the discretion of the Investigator. Acceptable birth control will be documented in the subject's case report form.
- Subjects must be willing to adhere to dosing schedules, study visits, and study requirements.
Who cannot join
- Clinically significant medical conditions (such as hepatic, neurological, hematological, renal, cardiac, gastrointestinal, endocrine, or other major systemic disease), which in the judgment of the Investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult.
- Clinically relevant abnormalities in laboratory results or electrocardiogram (ECG) as determined by the investigator
- Asthma that requires treatment other than with inhaled, short acting beta agonist alone.
- Female subjects who are pregnant, trying to become pregnant, or nursing.
- Nasal structural abnormalities, including large nasal polyps or marked septal deviation that significantly interfere with nasal airflow or nasal surgery within the past year.
- Upper respiratory infection within 3 weeks before the date of Randomization/Visit 2.
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- Treatment with any investigational drug in the last 30 days before the date of Randomization/Visit 2.
- History of drug or alcohol abuse that according to the Investigator could interfere with the study.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subjects unlikely to comply with study procedures, unable to return for study visits, or unlikely to complete the study, or expecting or planning to travel outside the area of the prevalent aeroallergen during the study period.
- History of hypersensitivity to steroids or to the excipients.
- Use of tricyclic antidepressants within the past 30 days prior to date of Randomization/Visit 2.
- Ocular herpes simplex or cataracts present at the time of Screening Visit.
About this study
Official title: A Phase II Multi-Center, Randomized, Double-Blind, Active and Placebo-Controlled 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation. The study does not have the power to determine how R926112 compares to Beconase.
Read the detailed description
Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the U.S. Approximately 375 patients, based on severity of symptoms will be randomized among the treatments (150 to R926112, 150 to placebo, 75 to Beconase). During, and for about 2-3 weeks prior to the study, patients will have to abstain from other anti-allergy medications. Patients will fill out diary cards two times per day to record their symptoms. The entire study should take between 2-4 weeks.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- R926112, Beclomethasone dipropionate
- Keywords
- Allergic Rhinitis, Nasal Spray, Seasonal Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R926112Drug
Beclomethasone dipropionateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total nasal symptom score from baseline over time
Secondary outcomes (3)
Change in individual symptoms
Global therapeutic response
Quality of life score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2005 (estimated)
- Study startJul 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- 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
- 375 participants
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elliott Grossbard, M.D., Study director, Rigel PharmaceuticalsEli Meltzer, M.D., Principal investigator, Allergy and Asthma Medical Group and Research Center, San DiegoHarold Nelson, M.D., Principal investigator, National Jewish Medical Research Center, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115089
- Sponsor's protocol ID
- C-926112-005A
- Status last verified
- Nov 2005
- First submitted
- 20 Jun 2005
- Last updated
- 11 Nov 2005
- Results posted
- No
Publications
Meltzer EO, Berkowitz RB, Grossbard EB. An intranasal Syk-kinase inhibitor (R112) improves the symptoms of seasonal allergic rhinitis in a park environment. J Allergy Clin Immunol. 2005 Apr;115(4):791-6. doi: 10.1016/j.jaci.2005.01.040.
PubMed 15806000
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Center, Randomized, Double-Blind, Active and Placebo-Controlled 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00115089
- Acronym / sponsor ID
- C-926112-005A
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Allergic Rhinitis, Nasal Spray, Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Sep 2005
- First posted
- 21 Jun 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.
This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation. The study does not have the power to determine how R926112 compares to Beconase.
Detailed description
Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the U.S. Approximately 375 patients, based on severity of symptoms will be randomized among the treatments (150 to R926112, 150 to placebo, 75 to Beconase). During, and for about 2-3 weeks prior to the study, patients will have to abstain from other anti-allergy medications. Patients will fill out diary cards two times per day to record their symptoms. The entire study should take between 2-4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must sign a written informed consent form and assent (if applicable) for study participation.
- Males and females, 12 years of age or older
- Subjects must have a history consistent with seasonal allergic rhinitis (SAR) during the fall pollen season for at least the previous 2 years.
- Subjects must be skin test positive to a relevant fall aeroallergen within the past 12 months with at least a moderate reaction as defined by at least a 5 mm wheal.
- Nasal exam to exclude significant swelling, bleeding, crusting, or polyps
Key exclusion criteria (13 listed)
- Clinically significant medical conditions (such as hepatic, neurological, hematological, renal, cardiac, gastrointestinal, endocrine, or other major systemic disease), which in the judgment of the Investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult.
- Clinically relevant abnormalities in laboratory results or electrocardiogram (ECG) as determined by the investigator
- Asthma that requires treatment other than with inhaled, short acting beta agonist alone.
- Female subjects who are pregnant, trying to become pregnant, or nursing.
- Nasal structural abnormalities, including large nasal polyps or marked septal deviation that significantly interfere with nasal airflow or nasal surgery within the past year.
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 |
|---|---|---|
| R926112 | Drug | – |
| Beclomethasone dipropionate | Drug | – |
Primary outcome
Change in total nasal symptom score from baseline over time
3 secondary outcomes
Change in individual symptoms
Global therapeutic response
Quality of life score
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 11 Nov 2005.
- Background: PubMed 15806000Meltzer EO, Berkowitz RB, Grossbard EB. An intranasal Syk-kinase inhibitor (R112) improves the symptoms of seasonal allergic rhinitis in a park environment. J Allergy Clin Immunol. 2005 Apr;115(4):791-6. doi: 10.1016/j.jaci.2005.01.040.
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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.
Elliott Grossbard, M.D. study director
Rigel Pharmaceuticals
Eli Meltzer, M.D. principal investigator
Allergy and Asthma Medical Group and Research Center, San Diego
Harold Nelson, M.D. principal investigator
National Jewish Medical Research Center, Denver
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R926112 and Beclomethasone dipropionate in people with Rhinitis, Allergic, Seasonal, run by Rigel Pharmaceuticals.
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 9 inclusion and 13 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 11 Nov 2005. 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?
Change in total nasal symptom score from baseline over time. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115089, which also lists 1 linked publication.
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 11 Nov 2005.