A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adults

NCT00604123 | Completed Phase 2 DMC

• 2 other identifiers: CR01404117166864NAP2001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.

Conditions

Allergic Rhinitis

Keywords

JNJ-17166864; allergic rhinitis; pharmacokinetics; biomarkers; rhinitis symptoms; mountain cedar pollen

Outcome Measures

Primary Outcomes (1)

• 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)

  allergic rhinitis symptom score during treatment phase (2 weeks)

Secondary Outcomes (1)

• To assess safety, tolerability, and pharmacokinetics

  pharmacokinetics and biomarker assessment during treatment phase (2 weeks)

Study Arms (2)

JNJ-17166864

EXPERIMENTAL

Drug: JNJ-17166864

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ-17166864 DRUG

JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.

JNJ-17166864

Placebo DRUG

Placebo nasal spray twice daily for 2 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 30, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

US (1)