Trial Outcomes & Findings for Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00723190)

Last Updated: 2018-04-18

Results Overview

Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

303 participants

Primary outcome timeframe

1 year

Results posted on

2018-04-18

Participant Flow

This was a multicenter study conducted at 27 study centers in the United States. First subject visit was on January 09, 2008 and last subject completed the study on March 08, 2010

Candidates enrolled in this study (CLON-303) were subjects who completed studies using KAPVAY (CLONICEL) as add-on therapy with stimulants (CLON-302) and as monotherapy (CLON-301). There was no screening period for this study. The safety follow-up visit from these two prior studies (CLON-301 and CLON-302) was the baseline visit for current study

Participant milestones

Participant milestones
Measure	KAPVAY (CLONICEL) One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Study STARTED	303
Overall Study SAFETY POPULATION	301
Overall Study COMPLETED	161
Overall Study NOT COMPLETED	142

Reasons for withdrawal

Reasons for withdrawal
Measure	KAPVAY (CLONICEL) One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Study Withdrawal by Subject	45
Overall Study Lost to Follow-up	37
Overall Study Adverse Event	18
Overall Study Lack of Efficacy	16
Overall Study Protocol Violation	15
Overall Study Other-Premature Discontinuation	9
Overall Study Other-Not included in safety population	2

Baseline Characteristics

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KAPVAY (CLONICEL) n=301 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Age, Continuous	10.0 Years n=5 Participants
Age, Customized 6-12 Years	239 Participants n=5 Participants
Age, Customized > 12-17 Years	62 Participants n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	221 Participants n=5 Participants
Race/Ethnicity, Customized White	186 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	69 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	25 Participants n=5 Participants
Race/Ethnicity, Customized Other	21 Participants n=5 Participants
Weight	38.1 Kilograms n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=301 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Total Safety Population	301 Participants
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Subjects with ≥1 TEAEs	246 Participants
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Subjects with ≥1 related TEAEs	178 Participants
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Subjects with ≥1 SAEs	2 Participants
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Subjects with ≥1 TEAEs leading to discontinuation	17 Participants

PRIMARY outcome

Timeframe: 1 year

Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=301 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Total number of TEAEs	954 Events
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Total number of related TEAEs	438 Events
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) Total number of SAEs	2 Events

PRIMARY outcome

Timeframe: At baseline and at Week 4

Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=280 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 QT	17.9 milliseconds Standard Deviation 25.69
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 QTcF	1.4 milliseconds Standard Deviation 16.42
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 QTcB	-8.0 milliseconds Standard Deviation 22.15

PRIMARY outcome

Timeframe: At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12

Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=301 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 week 1 (n = 283)	0.3 Kilograms Standard Deviation 2.25
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 week 2 (n = 283)	0.4 Kilograms Standard Deviation 2.28
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 week 3 (n = 278)	0.6 Kilograms Standard Deviation 2.39
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 week 4 (n = 269)	0.7 Kilograms Standard Deviation 2.42
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 2 (n = 246)	0.9 Kilograms Standard Deviation 2.61
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 3 (n = 232)	1.2 Kilograms Standard Deviation 2.97
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 4 (n = 212)	1.4 Kilograms Standard Deviation 3.25
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 5 (n = 47)	1.7 Kilograms Standard Deviation 5.63
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 6 (n = 204)	2.1 Kilograms Standard Deviation 3.84
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 9 (n = 123)	3.6 Kilograms Standard Deviation 3.72
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 month 12 (n = 123)	4.5 Kilograms Standard Deviation 4.83

PRIMARY outcome

Timeframe: At baseline and at Week 4

Population: Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=277 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Diastolic Blood Pressure at Week 4	-4.2 mmHg Standard Deviation 9.13

PRIMARY outcome

Timeframe: At baseline and at Week 4

Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=277 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Systolic Blood Pressure at Week 4	-5.0 mmHg Standard Deviation 10.71

PRIMARY outcome

Timeframe: At baseline and at Week 4

Population: Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=278 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Body Temperature at Week 4	-0.08 Fahrenheit Standard Deviation 0.791

PRIMARY outcome

Timeframe: At baseline and at Week 4

Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=277 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Heart Rate at Week 4	-7.0 beats per minute Standard Deviation 13.59

PRIMARY outcome

Timeframe: At baseline and at Week 4

Population: Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=280 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4	-10.6 beats per minute Standard Deviation 14.32

SECONDARY outcome

Timeframe: At baseline, months 1, 2, 3, 4, 6, 9, and 12

Population: Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement

The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=290 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 12-month (n = 98)	-14.6 Units on a scale Standard Deviation 14.05
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 1-month (n = 229)	-13.7 Units on a scale Standard Deviation 11.52
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 2-month (n = 221)	-14.4 Units on a scale Standard Deviation 11.73
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 3-month (n = 203)	-14.8 Units on a scale Standard Deviation 12.55
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 4-month (n = 142)	-16.3 Units on a scale Standard Deviation 12.59
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 6-month (n = 184)	-14.6 Units on a scale Standard Deviation 12.04
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 9-month (n = 119)	-18.1 Units on a scale Standard Deviation 12.66

SECONDARY outcome

Timeframe: At baseline, months 1, 2, 3, 4, 6, 9, and 12

CGI-S scale: 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=301 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 1-month (n = 229)	-1.2 Units on a scale Standard Deviation 1.17
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 2-month (n = 220)	-1.3 Units on a scale Standard Deviation 1.12
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 3-month (n = 202)	-1.3 Units on a scale Standard Deviation 1.29
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 4-month (n = 143)	-1.5 Units on a scale Standard Deviation 1.19
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 6-month (n = 185)	-1.4 Units on a scale Standard Deviation 1.15
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 9-month (n = 119)	-1.7 Units on a scale Standard Deviation 1.35
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 12-month (n = 97)	-1.4 Units on a scale Standard Deviation 1.46

SECONDARY outcome

Timeframe: At baseline, months 1, 2, 3, 4, 6, 9, and 12

CGI-I scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse

Outcome measures

Outcome measures
Measure	KAPVAY (CLONICEL) n=301 Participants One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 1-month (n = 229)	2.5 Units on a scale Standard Deviation 1.05
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 2-month (n = 220)	2.5 Units on a scale Standard Deviation 1.11
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 3-month (n = 202)	2.5 Units on a scale Standard Deviation 1.10
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 4-month (n = 143)	2.3 Units on a scale Standard Deviation 1.04
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 6-month (n = 185)	2.4 Units on a scale Standard Deviation 1.11
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 9-month (n = 119)	2.1 Units on a scale Standard Deviation 1.11
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 12-month (n = 97)	2.4 Units on a scale Standard Deviation 1.39

Adverse Events

KAPVAY (CLONICEL)

Serious events: 2 serious events

Other events: 246 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	KAPVAY (CLONICEL) n=301 participants at risk One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Psychiatric disorders Suicidal Behavior	0.33% 1/301 • 1 year
Infections and infestations Cellulitis	0.33% 1/301 • 1 year

Other adverse events

Other adverse events
Measure	KAPVAY (CLONICEL) n=301 participants at risk One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Psychiatric disorders Somnolence	31.9% 96/301 • 1 year
Psychiatric disorders Affect Lability	4.0% 12/301 • 1 year
Psychiatric disorders Emotional Disorder	2.0% 6/301 • 1 year
Gastrointestinal disorders Abdominal Pain Upper	12.3% 37/301 • 1 year
Gastrointestinal disorders Vomiting	5.6% 17/301 • 1 year
Gastrointestinal disorders Nausea	4.0% 12/301 • 1 year
Gastrointestinal disorders Diarrhoea	3.0% 9/301 • 1 year
Gastrointestinal disorders Constipation	2.7% 8/301 • 1 year
Infections and infestations Upper Respiratory Tract Infection	13.0% 39/301 • 1 year
Infections and infestations Gastroenteritis Viral	6.6% 20/301 • 1 year
Infections and infestations Nasopharyngitis	3.3% 10/301 • 1 year
Nervous system disorders Headache	16.3% 49/301 • 1 year
Nervous system disorders Insomnia	9.3% 28/301 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	8.3% 25/301 • 1 year
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.0% 18/301 • 1 year
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.3% 16/301 • 1 year
Respiratory, thoracic and mediastinal disorders Influenza	2.7% 8/301 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	2.0% 6/301 • 1 year
General disorders Fatigue	12.3% 37/301 • 1 year
General disorders Irritability	9.3% 28/301 • 1 year
Investigations Body Temperature Increased	7.3% 22/301 • 1 year
Investigations Weight Increased	3.7% 11/301 • 1 year
Metabolism and nutrition disorders Decreased Appetite	8.3% 25/301 • 1 year
Immune system disorders Rhinitis Seasonal	2.3% 7/301 • 1 year
Immune system disorders Dermatitis Contact	2.0% 6/301 • 1 year
Cardiac disorders Dizziness	3.0% 9/301 • 1 year
Injury, poisoning and procedural complications Hand Fracture	2.0% 6/301 • 1 year
Ear and labyrinth disorders Otitis Media Acute	2.0% 6/301 • 1 year
Skin and subcutaneous tissue disorders Rash	2.0% 6/301 • 1 year

Additional Information

Shionogi Clinical Trials Administrator

Shionogi USA

Phone: 800-849-9707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
Publication restrictions are in place

Restriction type: OTHER