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| ID | Type | Description | Link |
|---|---|---|---|
| 39220675ATT2001 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS) | The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mississauga | Ontario | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | JNJ-39220675 Then Pseudoephedrine Then Placebo | Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period. |
| FG001 | JNJ-39220675 Then Placebo Then Pseudoephedrine | Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period. |
| FG002 | Placebo Then JNJ-39220675 Then Pseudoephedrine | Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period. |
| FG003 | Placebo Then Pseudoephedrine Then JNJ-39220675 | Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period. |
| FG004 | Pseudoephedrine Then JNJ-39220675 Then Placebo | Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period. |
| FG005 | Pseudoephedrine Then Placebo Then JNJ-39220675 | Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period |
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| Period 2: Washout Period |
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| Period 3: Treatment Period |
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| Period 4: Washout Period |
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| Period 5: Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants randomized in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | square centimeter*hour (cm^2*h) | 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 |
Baseline up to End of Treatment (Day 41)
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director | Janssen Research and Development | 858-784-3111 |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D006967 | Hypersensitivity |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C559587 | (4-cyclobutyl-(1,4)diazepan-1-yl)-(6-(4-fluorophenoxy)pyridin-3-yl)methanone |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Pseudoephedrine | Drug | Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods. |
|
| 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 | The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline. | 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 | The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline. | Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods. |
| OG001 | JNJ-39220675 | Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods. |
| OG002 | Pseudoephedrine | Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods. |
|
|
|
| Secondary | Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS) | The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry). | The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale * hours | 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 |
|
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|
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| Secondary | 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 | The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline. | The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| Secondary | 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 | The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline. | The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | square centimeter (cm^2) | Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period |
|
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|
| 0 |
| 51 |
| 1 |
| 51 |
| EG001 | JNJ-39220675 | Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods. | 0 | 52 | 37 | 52 |
| EG002 | Pseudoephedrine | Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods. | 0 | 51 | 3 | 51 |
| Conjunctivitis allergic | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Mydriasis | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Autonomic nervous system imbalance | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| Least Squares Mean difference |
| 4.699 |
| Standard Error of the Mean |
| 2.289 |
| 95 |
| 0.155 |
| 9.243 |
| No |
| Superiority or Other |
| Linear mixed model | 0.0895 | Least Squares Mean difference | -3.905 | Standard Error of the Mean | 2.277 | 2-Sided | 95 | -8.424 | 0.614 | No | Superiority or Other |
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| Change at Hour 1.5 |
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| Change at Hour 2 |
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| Change at Hour 2.5 |
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| Change at Hour 3.0 |
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| Change at Hour 3.5 |
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| Change at Hour 4 |
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| Change at Hour 4.5 |
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| Change at Hour 5 |
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| Change at Hour 5.5 |
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| Change at Hour 6 |
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| Change at Hour 6.5 |
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| Change at Hour 7 |
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| Change at Hour 7.5 |
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| Change at Hour 8 |
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| Change at Hour 2 |
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| Change at Hour 3 |
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| Change at Hour 4 |
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| Change at Hour 5 |
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| Change at Hour 6 |
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| Change at Hour 7 |
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| Change at Hour 8 |
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