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

NCT00804687 | Completed Phase 2 Results

• 2 other identifiers: CR01570939220675ATT2001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Allergic Rhinitis

Keywords

Allergy; Rhinitis; Allergic Rhinitis; JNJ-39220675; Pseudoephedrine

Outcome Measures

Primary Outcomes (1)

• Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry

  The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber \[EEC\] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.

  2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Secondary Outcomes (3)

• Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)

  2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

• Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1

  0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

• Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1

  Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Study Arms (6)

JNJ-39220675 then Pseudoephedrine then Placebo

EXPERIMENTAL

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.

Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine

JNJ-39220675 then Placebo then Pseudoephedrine

EXPERIMENTAL

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.

Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine

Placebo then JNJ-39220675 then Pseudoephedrine

EXPERIMENTAL

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.

Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine

Placebo then Pseudoephedrine then JNJ-39220675

EXPERIMENTAL

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.

Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine

Pseudoephedrine then JNJ-39220675 then Placebo

EXPERIMENTAL

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.

Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine

Pseudoephedrine then Placebo then JNJ-39220675

EXPERIMENTAL

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.

Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine

Interventions

Placebo 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 then Placebo then Pseudoephedrine; JNJ-39220675 then Pseudoephedrine then Placebo; Placebo then JNJ-39220675 then Pseudoephedrine; Placebo then Pseudoephedrine then JNJ-39220675; Pseudoephedrine then JNJ-39220675 then Placebo; Pseudoephedrine then Placebo then JNJ-39220675

JNJ-39220675 DRUG

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

JNJ-39220675 then Placebo then Pseudoephedrine; JNJ-39220675 then Pseudoephedrine then Placebo; Placebo then JNJ-39220675 then Pseudoephedrine; Placebo then Pseudoephedrine then JNJ-39220675; Pseudoephedrine then JNJ-39220675 then Placebo; Pseudoephedrine then Placebo then JNJ-39220675

Pseudoephedrine DRUG

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

JNJ-39220675 then Placebo then Pseudoephedrine; JNJ-39220675 then Pseudoephedrine then Placebo; Placebo then JNJ-39220675 then Pseudoephedrine; Placebo then Pseudoephedrine then JNJ-39220675; Pseudoephedrine then JNJ-39220675 then Placebo; Pseudoephedrine then Placebo then JNJ-39220675

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity; Rhinitis

Interventions

(4-cyclobutyl-(1,4)diazepan-1-yl)-(6-(4-fluorophenoxy)pyridin-3-yl)methanone; Pseudoephedrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Senior Medical Director
• Organization: Janssen Research and Development

858-784-3111

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 30, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-09

Locations

CA (1)