Allergic RhinitisPhase 2NCT00604123
A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adults
A Phase 2 study testing JNJ-17166864 in people with Allergic Rhinitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- JNJ-17166864
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a clinical history of seasonal allergic rhinitis with onset and offset of nasal allergy symptoms during each of the past 2 mountain cedar allergy seasons
- Have positive prick skin test reaction to mountain cedar allergen at screening or have a documented positive prick skin test within 12 months prior to entering the treatment phase
- Good general health on the basis of physical examination (including nasal examination), medical history, vital signs, and 12-lead ECG performed at screening and on Day -2
- Good general health on the basis of clinical laboratory tests performed at screening
- Have no history of recent (within 14 days prior to study drug administration on Day 1) common cold or recent (within 14 days prior to study drug administration on Day 1) occupational exposures to inhaled irritants (e.g., industrial gases, dusts, pesticides) with the exception of mountain cedar pollen
- Have no history of recurrent or frequent epistaxis or recent episodes (within 14 days prior to study drug administration on Day 1) of nose bleeding
- Non-smoker or non-tobacco user (not smoked cigarettes or used tobacco-containing or nicotine-containing products for at least 3 months prior to screening.
Who cannot join
- Have asthma (Note: subjects with mild intermittent asthma are allowed)
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super-potent topical corticosteroids
- Use of any antihistamines during the study
- Under immunotherapy with mountain cedar extract
- Using prohibited medications or not having adequate washout period (prior to the start of Run-in) as specified: Intranasal or systemic corticosteroids (1 month), Intranasal cromolyn (2 weeks), Intranasal or systemic decongestants (3 days), Intranasal or systemic antihistamines (7 days), Intranasal tryptans,e.g. sumatryptan nasal spray, Imitrex (3 days), Intranasal ergotamines, e.g. dihydroergotamine mesylate nasal spray, Migranol (7 days), Singulair (7 days), Niaspan® extended-release tablets, or immediate release niacin (10 days)
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
- Chronic use of concomitant medications including prescription medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication within 14 days prior to study drug administration on Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adult Men or Women Allergic to Mountain Cedar Pollen
The purpose of this study is to evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.
Read the detailed description
The study is conducted to prove the hypothesis that JNJ-17466864, as compared to placebo, can provide a 16% or greater improvement in nasal symptoms of seasonal allergic rhinitis. This is a randomized, blinded, placebo-controlled, parallel-group, 2-center outpatient study in adult men or women who have seasonal allergic rhinitis and have 2 year history (or longer) of mild to moderate allergic reaction to mountain cedar pollen. The study will be conducted in mountain cedar pollen season. 72 qualified patients will be admitted to the single-blind 7-day Run-in Period (placebo twice daily) to establish the Baseline allergic rhinitis symptom scores. Patient eligibility to enter the double-blind treatment phase will be based on patients' baseline nasal symptom scores. At least 66 eligible patients whose daytime average nasal symptom scores (of nasal congestion, nasal itching, rhinorrhea, and sneezing) is 2 or greater, with the daytime nasal congestion symptom score 2 or greater, on at least 4 of the 7 Run-in days will be admitted to the double-blind treatment phase, and randomized to either the JNJ-17166864 or placebo treatment group. During the Treatment Phase, patients will self-administer study medication (0.5 mg JNJ-17166864 or placebo per nostril) twice daily for 2 weeks, record allergic rhinitis nasal and ocular symptom scores, and complete the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), to establish the In-Treatment scores. Pharmacokinetic and biomarker samples will be collected during treatment phase. Throughout the study, safety and tolerability will be assessed.
- Conditions
- Allergic Rhinitis
- Being tested
- JNJ-17166864, Placebo
- Keywords
- JNJ-17166864, allergic rhinitis, pharmacokinetics, biomarkers, rhinitis symptoms, mountain cedar pollen
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-17166864Drug
JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.
PlaceboDrug
Placebo nasal spray twice daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-17166864 | Experimental | Not described Receives: Drug: JNJ-17166864 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of twice daily dosing of intranasal JNJ-17166864, compared to placebo, on nasal symptoms of seasonal allergic rhinitis (nasal congestion, nasal itching, rhinorrhea, and sneezing)
Measured: allergic rhinitis symptom score during treatment phase (2 weeks)
Secondary outcomes (1)
To assess safety, tolerability, and pharmacokinetics
Measured: pharmacokinetics and biomarker assessment during treatment phase (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604123
- Sponsor's protocol ID
- CR014041
- Other IDs
- 17166864NAP2001
- Status last verified
- Apr 2015
- First submitted
- 8 Jan 2008
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adult Men or Women Allergic to Mountain Cedar Pollen
- ClinicalTrials.gov ID
- NCT00604123
- Acronym / sponsor ID
- CR014041
- Conditions
- Allergic Rhinitis
- Keywords
- JNJ-17166864, allergic rhinitis, pharmacokinetics, biomarkers, rhinitis symptoms, mountain cedar pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 30 Jan 2008 (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 evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.
Detailed description
The study is conducted to prove the hypothesis that JNJ-17466864, as compared to placebo, can provide a 16% or greater improvement in nasal symptoms of seasonal allergic rhinitis. This is a randomized, blinded, placebo-controlled, parallel-group, 2-center outpatient study in adult men or women who have seasonal allergic rhinitis and have 2 year history (or longer) of mild to moderate allergic reaction to mountain cedar pollen. The study will be conducted in mountain cedar pollen season. 72 qualified patients will be admitted to the single-blind 7-day Run-in Period (placebo twice daily) to establish the Baseline allergic rhinitis symptom scores. Patient eligibility to enter the double-blind treatment phase will be based on patients' baseline nasal symptom scores. At least 66 eligible patients whose daytime average nasal symptom scores (of nasal congestion, nasal itching, rhinorrhea, and sneezing) is 2 or greater, with the daytime nasal congestion symptom score 2 or greater, on at least 4 of the 7 Run-in days will be admitted to the double-blind treatment phase, and randomized to either the JNJ-17166864 or placebo treatment group. During the Treatment Phase, patients will self-administer study medication (0.5 mg JNJ-17166864 or placebo per nostril) twice daily for 2 weeks, record allergic rhinitis nasal and ocular symptom scores, and complete the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), to establish the In-Treatment scores. Pharmacokinetic and biomarker samples will be collected during treatment phase. Throughout the study, safety and tolerability will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-17166864 | Experimental | Drug: JNJ-17166864 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have a clinical history of seasonal allergic rhinitis with onset and offset of nasal allergy symptoms during each of the past 2 mountain cedar allergy seasons
- Have positive prick skin test reaction to mountain cedar allergen at screening or have a documented positive prick skin test within 12 months prior to entering the treatment phase
- Good general health on the basis of physical examination (including nasal examination), medical history, vital signs, and 12-lead ECG performed at screening and on Day -2
- Good general health on the basis of clinical laboratory tests performed at screening
- Have no history of recent (within 14 days prior to study drug administration on Day 1) common cold or recent (within 14 days prior to study drug administration on Day 1) occupational exposures to inhaled irritants (e.g., industrial gases, dusts, pesticides) with the exception of mountain cedar pollen
Key exclusion criteria (7 listed)
- Have asthma (Note: subjects with mild intermittent asthma are allowed)
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super-potent topical corticosteroids
- Use of any antihistamines during the study
- Under immunotherapy with mountain cedar extract
- Using prohibited medications or not having adequate washout period (prior to the start of Run-in) as specified: Intranasal or systemic corticosteroids (1 month), Intranasal cromolyn (2 weeks), Intranasal or systemic decongestants (3 days), Intranasal or systemic antihistamines (7 days), Intranasal tryptans,e.g. sumatryptan nasal spray, Imitrex (3 days), Intranasal ergotamines, e.g. dihydroergotamine mesylate nasal spray, Migranol (7 days), Singulair (7 days), Niaspan® extended-release tablets, or immediate release niacin (10 days)
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 |
|---|---|---|
| JNJ-17166864JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks. | Drug | JNJ-17166864 |
| PlaceboPlacebo nasal spray twice daily for 2 weeks. | Drug | Placebo |
Primary outcome
To determine the effect of twice daily dosing of intranasal JNJ-17166864, compared to placebo, on nasal symptoms of seasonal allergic rhinitis (nasal congestion, nasal itching, rhinorrhea, and sneezing)
Time frame: allergic rhinitis symptom score during treatment phase (2 weeks)
1 secondary outcome
To assess safety, tolerability, and pharmacokinetics
Time frame: pharmacokinetics and biomarker assessment during treatment phase (2 weeks)
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 29 Apr 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-17166864 in people with Allergic Rhinitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
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 7 inclusion and 7 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
To determine the effect of twice daily dosing of intranasal JNJ-17166864, compared to placebo, on nasal symptoms of seasonal allergic rhinitis (nasal congestion, nasal itching, rhinorrhea, and sneezing) (time frame: allergic rhinitis symptom score during treatment phase (2 weeks)). 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 29 Apr 2015.