Trial Outcomes & Findings for An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis (NCT NCT00804687)

Last Updated: 2013-10-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

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

Results posted on

2013-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.
Period 1: Treatment Period STARTED	9	9	9	9	9	8
Period 1: Treatment Period COMPLETED	9	9	9	9	9	8
Period 1: Treatment Period NOT COMPLETED	0	0	0	0	0	0
Period 2: Washout Period STARTED	9	9	9	9	9	8
Period 2: Washout Period COMPLETED	9	9	9	9	9	8
Period 2: Washout Period NOT COMPLETED	0	0	0	0	0	0
Period 3: Treatment Period STARTED	9	9	9	9	9	8
Period 3: Treatment Period COMPLETED	9	9	9	8	9	8
Period 3: Treatment Period NOT COMPLETED	0	0	0	1	0	0
Period 4: Washout Period STARTED	9	9	9	8	9	8
Period 4: Washout Period COMPLETED	9	9	9	8	9	8
Period 4: Washout Period NOT COMPLETED	0	0	0	0	0	0
Period 5: Treatment Period STARTED	9	9	9	8	9	8
Period 5: Treatment Period COMPLETED	8	9	8	8	8	8
Period 5: Treatment Period NOT COMPLETED	1	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Period 3: Treatment Period Positive Drug screen	0	0	1	0
Period 5: Treatment Period Withdrawal by Subject	0	0	0	1
Period 5: Treatment Period Positive drugs of abuse	0	1	0	0
Period 5: Treatment Period Positive drug test	1	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=53 Participants Includes all participants randomized in the study.
Age Continuous	41.9 years STANDARD_DEVIATION 11.8 • n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	38 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	JNJ-39220675 n=52 Participants Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Pseudoephedrine n=51 Participants Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry	-0.682 square centimeterhour (cm^2h) Standard Deviation 0.803	-0.504 square centimeterhour (cm^2h) Standard Deviation 0.805	-0.550 square centimeterhour (cm^2h) Standard Deviation 0.843

SECONDARY outcome

Timeframe: 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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	JNJ-39220675 n=52 Participants Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Pseudoephedrine n=51 Participants Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)	45.720 units on a scale * hours Standard Deviation 24.707	36.536 units on a scale * hours Standard Deviation 24.322	43.195 units on a scale * hours Standard Deviation 26.202

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	JNJ-39220675 n=52 Participants Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Pseudoephedrine n=51 Participants Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
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 Change at Hour 0.5	2.7 units on a scale Standard Deviation 3.0	1.4 units on a scale Standard Deviation 2.5	1.7 units on a scale Standard Deviation 2.4
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 Change at Hour 1	3.5 units on a scale Standard Deviation 3.5	2.2 units on a scale Standard Deviation 2.9	3.4 units on a scale Standard Deviation 3.6
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 Change at Hour 1.5	4.1 units on a scale Standard Deviation 3.8	3.2 units on a scale Standard Deviation 3.3	4.2 units on a scale Standard Deviation 3.7
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 Change at Hour 2	5.0 units on a scale Standard Deviation 3.6	3.9 units on a scale Standard Deviation 3.5	4.6 units on a scale Standard Deviation 3.8
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 Change at Hour 2.5	5.6 units on a scale Standard Deviation 3.7	4.1 units on a scale Standard Deviation 3.3	5.0 units on a scale Standard Deviation 3.7
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 Change at Hour 3.0	5.8 units on a scale Standard Deviation 3.6	4.7 units on a scale Standard Deviation 3.5	5.4 units on a scale Standard Deviation 3.5
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 Change at Hour 3.5	5.6 units on a scale Standard Deviation 3.5	4.9 units on a scale Standard Deviation 3.5	5.6 units on a scale Standard Deviation 3.6
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 Change at Hour 4	6.1 units on a scale Standard Deviation 3.6	5.4 units on a scale Standard Deviation 3.3	6.0 units on a scale Standard Deviation 3.8
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 Change at Hour 4.5	6.4 units on a scale Standard Deviation 3.4	5.3 units on a scale Standard Deviation 3.8	5.6 units on a scale Standard Deviation 3.8
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 Change at Hour 5	6.5 units on a scale Standard Deviation 3.4	5.3 units on a scale Standard Deviation 3.7	6.3 units on a scale Standard Deviation 3.6
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 Change at Hour 5.5	6.6 units on a scale Standard Deviation 3.2	5.4 units on a scale Standard Deviation 3.6	6.4 units on a scale Standard Deviation 3.7
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 Change at Hour 6	6.9 units on a scale Standard Deviation 3.5	5.6 units on a scale Standard Deviation 3.5	6.5 units on a scale Standard Deviation 3.6
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 Change at Hour 6.5	7.0 units on a scale Standard Deviation 3.4	5.7 units on a scale Standard Deviation 3.5	6.8 units on a scale Standard Deviation 3.8
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 Change at Hour 7	7.0 units on a scale Standard Deviation 3.5	6.1 units on a scale Standard Deviation 3.5	6.9 units on a scale Standard Deviation 3.7
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 Change at Hour 7.5	7.0 units on a scale Standard Deviation 3.6	6.1 units on a scale Standard Deviation 3.3	6.9 units on a scale Standard Deviation 3.5
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 Change at Hour 8	7.4 units on a scale Standard Deviation 3.4	6.5 units on a scale Standard Deviation 3.3	7.0 units on a scale Standard Deviation 3.6

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	JNJ-39220675 n=52 Participants Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Pseudoephedrine n=51 Participants Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
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	0.304 square centimeter (cm^2) Standard Deviation 0.106	0.294 square centimeter (cm^2) Standard Deviation 0.121	0.312 square centimeter (cm^2) Standard Deviation 0.116
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 Change at Hour 1	-0.054 square centimeter (cm^2) Standard Deviation 0.112	-0.028 square centimeter (cm^2) Standard Deviation 0.118	-0.035 square centimeter (cm^2) Standard Deviation 0.118
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 Change at Hour 2	-0.048 square centimeter (cm^2) Standard Deviation 0.122	-0.041 square centimeter (cm^2) Standard Deviation 0.112	0.060 square centimeter (cm^2) Standard Deviation 0.111
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 Change at Hour 3	-0.086 square centimeter (cm^2) Standard Deviation 0.114	-0.055 square centimeter (cm^2) Standard Deviation 0.117	-0.053 square centimeter (cm^2) Standard Deviation 0.115
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 Change at Hour 4	-0.100 square centimeter (cm^2) Standard Deviation 0.105	-0.077 square centimeter (cm^2) Standard Deviation 0.125	-0.072 square centimeter (cm^2) Standard Deviation 0.119
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 Change at Hour 5	-0.104 square centimeter (cm^2) Standard Deviation 0.124	-0.082 square centimeter (cm^2) Standard Deviation 0.105	-0.092 square centimeter (cm^2) Standard Deviation 0.127
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 Change at Hour 6	-0.108 square centimeter (cm^2) Standard Deviation 0.117	-0.091 square centimeter (cm^2) Standard Deviation 0.116	-0.081 square centimeter (cm^2) Standard Deviation 0.148
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 Change at Hour 7	-0.094 square centimeter (cm^2) Standard Deviation 0.135	-0.079 square centimeter (cm^2) Standard Deviation 0.125	-0.099 square centimeter (cm^2) Standard Deviation 0.124
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 Change at Hour 8	-0.111 square centimeter (cm^2) Standard Deviation 0.119	-0.090 square centimeter (cm^2) Standard Deviation 0.139	-0.110 square centimeter (cm^2) Standard Deviation 0.115

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

JNJ-39220675

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Pseudoephedrine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Medical Director

Janssen Research and Development

Phone: 858-784-3111

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Other adverse events
Measure	Placebo n=51 participants at risk Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	JNJ-39220675 n=52 participants at risk Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Pseudoephedrine n=51 participants at risk Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Cardiac disorders Palpitations	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Eye disorders Conjunctivitis allergic	2.0% 1/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Eye disorders Mydriasis	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Gastrointestinal disorders Dry mouth	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Gastrointestinal disorders Nausea	0.00% 0/51 • 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.	13.5% 7/52 • 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.	0.00% 0/51 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Nervous system disorders Disturbance in attention	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Nervous system disorders Dizziness	0.00% 0/51 • 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.	3.8% 2/52 • 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.	0.00% 0/51 • 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.
Nervous system disorders Headache	0.00% 0/51 • 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.	9.6% 5/52 • 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.	2.0% 1/51 • 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.
Nervous system disorders Tremor	0.00% 0/51 • 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.	0.00% 0/52 • 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.	2.0% 1/51 • 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.
Psychiatric disorders Anxiety	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Psychiatric disorders Insomnia	0.00% 0/51 • 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.	17.3% 9/52 • 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.	0.00% 0/51 • 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.
Psychiatric disorders Nightmare	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/51 • 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.	0.00% 0/52 • 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.	2.0% 1/51 • 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.
Metabolism and nutrition disorders Anorexia	0.00% 0/51 • 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.	1.9% 1/52 • 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.	0.00% 0/51 • 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.