MedDataX Logo

An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis

NCT ID: NCT00804687

Last Updated: 2013-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and pseudoephedrine compared to placebo (medication with no active ingredients) in participants with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen, dust or animal hair).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized (the study drug is assigned by chance), single-dose, single-blind (a clinical trial in which the person giving the treatment, but not the participant, knows which treatment the participant is receiving), double-dummy, placebo-controlled, three-treatment period, cross-over (participants may receive different interventions sequentially during the trial) study of JNJ-39220675 in participants with allergic rhinitis. The duration of study will be 20-64 days per participant. The study consists of 2 parts: Screening (that is, 30 days before study commences on Day 1) and Treatment (consists of single-dose of either JNJ-39220675 solution \[10 milligram\], Pseudoephedrine tablet \[60 milligram\] or Placebo, in subsequent three-treatment periods, each separated with washout period of 6 days). All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. Participants will be given dose approximately 2 hours before entry into the environmental exposure chamber where they will be exposed to ragweed pollen for 8 hours. Efficacy will primarily be evaluated by measurement of nasal congestion that will be assessed through nasal cavity geometry that is, minimal cross-sectional area of nasal cavity by Acoustic rhinometry. Participants' safety will be monitored throughout the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Rhinitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Allergy Rhinitis Allergic Rhinitis JNJ-39220675 Pseudoephedrine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

JNJ-39220675 then Pseudoephedrine then Placebo

Single-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudoephedrine tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

JNJ-39220675

Intervention Type DRUG

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Pseudoephedrine

Intervention Type DRUG

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

JNJ-39220675 then Placebo then Pseudoephedrine

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

JNJ-39220675

Intervention Type DRUG

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Pseudoephedrine

Intervention Type DRUG

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Placebo then JNJ-39220675 then Pseudoephedrine

Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

JNJ-39220675

Intervention Type DRUG

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Pseudoephedrine

Intervention Type DRUG

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Placebo then Pseudoephedrine then JNJ-39220675

Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

JNJ-39220675

Intervention Type DRUG

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Pseudoephedrine

Intervention Type DRUG

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Pseudoephedrine then JNJ-39220675 then Placebo

Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

JNJ-39220675

Intervention Type DRUG

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Pseudoephedrine

Intervention Type DRUG

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Pseudoephedrine then Placebo then JNJ-39220675

Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

JNJ-39220675

Intervention Type DRUG

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Pseudoephedrine

Intervention Type DRUG

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

Intervention Type OTHER

JNJ-39220675

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Intervention Type DRUG

Pseudoephedrine

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants must have a clinical history of seasonal allergic rhinitis with seasonal onset and offset of nasal allergy symptoms at least during each of the last two ragweed allergy seasons
* Participants must have documentation of a positive skin test within 12 months of Screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test (allergy tests performed by injecting allergy-causing substances underneath the skin to see if they cause a reaction) for ragweed allergen
* Female participants must not be pregnant, lactating or be able to become pregnant
* Male participants must consent to use a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed
* Participants with body mass index between 18 and 32 kilogram per square meter

Exclusion Criteria

* Participants with clinically significant physical findings of nasal anatomical deformities
* Participants with a history of risk factors for torsades de pointes (heart failure, hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT or QTc interval or an abnormal 12-lead electrocardiogram except for clinically non-significant bradycardia
* Participants with history of exposure to an investigational treatment within the 30 days before the Screening Visit, or has ever taken JNJ-39220675 previously
* Participants with a history of clinically significant allergies, especially known hypersensitivity or intolerance to any drug or known allergy to the study drug or any of the excipients of the formulation
* Participants with a history of severe respiratory infection or disorder, epilepsy or seizures, coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease, or history of a positive test for Human immuno-deficiency (HIV), Hepatitis B or Hepatitis C
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mississauga, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

39220675ATT2001

Identifier Type: -

Identifier Source: secondary_id

CR015709

Identifier Type: -

Identifier Source: org_study_id