Trial Outcomes & Findings for Novel Smoking Cessation Drug for Schizophrenia (NCT NCT02230384)

NCT ID: NCT02230384

Last Updated: 2019-04-02

Results Overview

Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week) Numbers reported are collapsed across medication conditions for each medication order.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: Daily - Mon-Fri during the quit week in each phase
• Results posted on: 2019-04-02

Participant Flow

Participant milestones

Measure	Active JNJ Drug Then Placebo 200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number. Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week	Placebo Pill Then Active JNJ Drug Placebo pill used for one week quit attempt, as part of crossover design. Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week
Phase 1 STARTED	30	32
Phase 1 COMPLETED	29	31
Phase 1 NOT COMPLETED	1	1
Phase 1 Wash Out STARTED	29	31
Phase 1 Wash Out COMPLETED	29	31
Phase 1 Wash Out NOT COMPLETED	0	0
Phase 2 - Switch STARTED	29	31
Phase 2 - Switch COMPLETED	26	30
Phase 2 - Switch NOT COMPLETED	3	1
Phase 2 Wash Out STARTED	26	30
Phase 2 Wash Out COMPLETED	26	30
Phase 2 Wash Out NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Active JNJ Drug Then Placebo 200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number. Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week	Placebo Pill Then Active JNJ Drug Placebo pill used for one week quit attempt, as part of crossover design. Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week
Phase 1 Lost to Follow-up	1	0
Phase 1 Physician Decision	0	1
Phase 2 - Switch Withdrawal by Subject	0	1
Phase 2 - Switch Lost to Follow-up	1	0
Phase 2 - Switch Adverse Event	2	0

Baseline Characteristics

Novel Smoking Cessation Drug for Schizophrenia

Baseline characteristics by cohort

Measure	Active JNJ Drug Then Placebo n=30 Participants 200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number. Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week	Placebo Pill Then Active JNJ Drug n=32 Participants Placebo pill used for one week quit attempt, as part of crossover design. Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	46.06 years STANDARD_DEVIATION 11.31 • n=93 Participants	46.31 years STANDARD_DEVIATION 10.97 • n=4 Participants	46.19 years STANDARD_DEVIATION 11.04 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	19 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment United States	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants

PRIMARY outcome

Timeframe: Daily - Mon-Fri during the quit week in each phase

Population: All participants who completed Phase 1 and Phase 2 of the of the study were included in the analysis.

Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week)

Numbers reported are collapsed across medication conditions for each medication order.

Outcome measures

Measure	Active JNJ Drug n=56 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=56 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Quit Status	0.46 days abstinent Standard Error 0.151	0.54 days abstinent Standard Error 0.173

SECONDARY outcome

Timeframe: during each quit week

Population: Participants who met CO \< 5 ppm quit criterion.

Severity of withdrawal symptoms will be assessed with standard self-report measures each day during the quit week only of each phase. Data will be analysed when quit criteria were met. Scale used was the Minnesota Nicotine Withdrawal Scale (MNWS), ranging from 0 to 100, with higher scores indicating greater levels of withdrawal symptoms. The MNWS was completed 5 times for each participant during the quit week of each phase. The mean score was used to aggregate across visits.

Outcome measures

Measure	Active JNJ Drug n=15 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=15 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Withdrawal When Quit	11.05 score on a scale Standard Error 2.86	11.52 score on a scale Standard Error 1.77

SECONDARY outcome

Timeframe: Assessed at the end of both treatment phases, i.e., at the end of 3 and 6 weeks.

Population: those who met the CO \< 10 smoking reduction criteria at the end of both treatment phases

Performance on standardized cognitive tasks (Continuous Performance Task) to determine potential mechanisms of drug efficacy when CO < 10 smoking reduction criteria was met for both sessions. The Continuous Performance Test provides assesses sustained attention in milliseconds.

Outcome measures

Measure	Active JNJ Drug n=6 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=6 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Cognitive Functions	519 milliseconds Standard Error 37	505 milliseconds Standard Error 29

SECONDARY outcome

Timeframe: Once at every scheduled visit

Psychiatric symptoms using Positive and Negative Syndrome Scale (PANSS) will be conducted at each visit in each 3 week phase of the study

PANSS - Positive and Negative Syndrome Scale. Min value 30, Max value 210, higher scores are worse outcome.

The mean score was used to aggregate across visits.

Outcome measures

Measure	Active JNJ Drug n=56 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=56 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Monitoring of Psychiatric Symptoms Including Psychopathology	42.23 score on a scale Standard Deviation 7.79	42.26 score on a scale Standard Deviation 7.63

SECONDARY outcome

Timeframe: Every visit up to six weeks. It is only significant when there is a positive response "Yes"

CSSRS: Columbia Suicide Severity rating Scale. The scale assesses treatment emergent suicidal ideation and/or behavior categorically as a YES/NO response (no min/max score). "No" responses indicate ideation/behaviors did not emerge "Yes" responses indicate there were ideation or behaviors We are reporting the number of participants that met criteria for suicidal ideation or behavior, based on their CSSRS assessment

Outcome measures

Measure	Active JNJ Drug n=56 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=56 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Number of Participants That Met Criteria for Treatment Emergent Suicidal Ideation or Behavior	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 0, 2, 3, 5, 6

Population: Intent to treat population (all participants who received at least one dose of intervention)

Routine safety labs (included liver and renal labs) were done at baseline, Visit 9, and Visit 18 to determine whether there were treatment emergent clinically significant changes in any of the laboratory parameters. (no subject with abnormal labs at baseline were enrolled in the study) In addition, liver and renal labs were drawn at Visit 4 and Visit 13 to assess for treatment emergent, clinically significant abnormal liver and renal functions.

The reported results in the data table below show the number of subjects that had treatment emergent clinically significant abnormal lab results at any of the time points.

If labs were not within the normal range, they were reviewed by the physician investigators to determine whether they were clinically significant.

Outcome measures

Measure	Active JNJ Drug n=26 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=30 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results Liver and Renal Labs Only Wk 2	0 Participants	0 Participants
Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results Routine Labs (including Liver and Renal) Week 3	0 Participants	0 Participants
Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results Liver and Renal Labs Only Wk 5	0 Participants	0 Participants
Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results Routine Labs (including Liver and Renal) Week 6	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and end of study (week 6)

Population: Intent to treat population (all participants who received at least on dose of intervention)

EKG measures were done at the screening visit and at the end of study to determine whether there were treatment emergent clinically significant changes in the EKG parameters.

No subjects with abnormal EKGs at baseline were enrolled in the study The data table below shows the number of subjects with clinically significant abnormal EKG results at the end of the study.

Outcome measures

Measure	Active JNJ Drug n=26 Participants Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo Pill n=30 Participants Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
The Number of Participants Who Had Treatment Emergent Clinically Significant EKG Results	0 Participants	0 Participants

Adverse Events

JNJ Drug

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	JNJ Drug n=60 participants at risk Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo n=61 participants at risk Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Immune system disorders aspiration/pneumonia	0.00% 0/60 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	1.6% 1/61 • Number of events 1 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Cardiac disorders acute diastolic congestive heart failure	0.00% 0/60 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	1.6% 1/61 • Number of events 1 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Gastrointestinal disorders persistent vomiting	0.00% 0/60 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	1.6% 1/61 • Number of events 1 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Gastrointestinal disorders abdominal pain	1.7% 1/60 • Number of events 1 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	0.00% 0/61 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Reproductive system and breast disorders vaginal bleeding	1.7% 1/60 • Number of events 1 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	0.00% 0/61 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.

Other adverse events

Measure	JNJ Drug n=60 participants at risk Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)	Placebo n=61 participants at risk Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
Gastrointestinal disorders Diarrhea	6.7% 4/60 • Number of events 4 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	13.1% 8/61 • Number of events 10 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Gastrointestinal disorders Nausea	6.7% 4/60 • Number of events 5 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	11.5% 7/61 • Number of events 8 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Nervous system disorders Headache	5.0% 3/60 • Number of events 3 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	8.2% 5/61 • Number of events 7 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Nervous system disorders Somnolence	8.3% 5/60 • Number of events 5 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	1.6% 1/61 • Number of events 1 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Cardiac disorders Tachycardia	5.0% 3/60 • Number of events 5 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	3.3% 2/61 • Number of events 3 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Musculoskeletal and connective tissue disorders Muscle pain/soreness	3.3% 2/60 • Number of events 2 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	8.2% 5/61 • Number of events 5 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Respiratory, thoracic and mediastinal disorders Cold/nasal congestion	3.3% 2/60 • Number of events 2 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	6.6% 4/61 • Number of events 4 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 3/60 • Number of events 3 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	4.9% 3/61 • Number of events 3 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.
General disorders Fever	6.7% 4/60 • Number of events 4 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.	1.6% 1/61 • Number of events 3 • 6 weeks Cross-Over study, all subjects received both JNJ and Placebo. Tables below reflect whether the event occurred during the receipt of JNJ or during the receipt of placebo. 62 subjects were randomized, of whom 7 did not complete the study. Of those 7, 3 were exposed to both JNJ and Placebo, 1 was exposed to the JNJ condition only, 2 were exposed to the placebo condition only and 1 was not exposed to either condition. Thus 60 subjects were exposed to JNJ and 61 subjects were exposed to placebo.

Additional Information

K.N. Roy Chengappa, MD / Principal Investigator

University of Pittsburgh

Phone: 412-246-5006

Email: chengappakn@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place