Trial Outcomes & Findings for An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). (NCT NCT00192023)
NCT ID: NCT00192023
Last Updated: 2010-01-18
Results Overview
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
Visit 8 (baseline) and Visit 14 (8 weeks)
Results posted on
2010-01-18
Participant Flow
Study Period I=Screening. Study Period II=Standardized behavioral management program for parents (156 entered, 17 discontinued). Study Period III=Double-Blind (randomization). Two patients did not have post-baseline values for the primary endpoint and were not included in Baseline or efficacy analyses. Study Period IV=Optional open-label phase.
Participant milestones
| Measure |
Atomoxetine
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Period III - Double-Blind
STARTED
|
107
|
32
|
|
Period III - Double-Blind
COMPLETED
|
100
|
32
|
|
Period III - Double-Blind
NOT COMPLETED
|
7
|
0
|
|
Period IV - Optional Open-Label
STARTED
|
124
|
0
|
|
Period IV - Optional Open-Label
COMPLETED
|
49
|
0
|
|
Period IV - Optional Open-Label
NOT COMPLETED
|
75
|
0
|
Reasons for withdrawal
| Measure |
Atomoxetine
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Period III - Double-Blind
Adverse Event
|
3
|
0
|
|
Period III - Double-Blind
Physician Decision
|
2
|
0
|
|
Period III - Double-Blind
Parent/Caregiver Decision
|
2
|
0
|
|
Period IV - Optional Open-Label
Adverse Event
|
6
|
0
|
|
Period IV - Optional Open-Label
Lack of Efficacy
|
7
|
0
|
|
Period IV - Optional Open-Label
Patient/Caregiver Decision
|
46
|
0
|
|
Period IV - Optional Open-Label
Lost to Follow-up
|
2
|
0
|
|
Period IV - Optional Open-Label
Protocol Violation
|
1
|
0
|
|
Period IV - Optional Open-Label
Withdrawal by Subject
|
4
|
0
|
|
Period IV - Optional Open-Label
Physician Decision
|
9
|
0
|
Baseline Characteristics
An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=105 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
9.7 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
9.8 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
105 participants
n=5 Participants
|
32 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
104 participants
n=5 Participants
|
29 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Height
|
140.1 centimeters
STANDARD_DEVIATION 15.2 • n=5 Participants
|
141.6 centimeters
STANDARD_DEVIATION 15.3 • n=7 Participants
|
140.4 centimeters
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Weight
|
39.3 kilograms
STANDARD_DEVIATION 15.8 • n=5 Participants
|
41.4 kilograms
STANDARD_DEVIATION 14.1 • n=7 Participants
|
39.8 kilograms
STANDARD_DEVIATION 15.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.
Outcome measures
| Measure |
Atomoxetine
n=105 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale
Baseline
|
42.7 units on a scale
Standard Deviation 6.2
|
41.5 units on a scale
Standard Deviation 6.9
|
|
Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale
Change to 8 Week Endpoint
|
-8.1 units on a scale
Standard Deviation 9.2
|
-2.0 units on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Outcome measures
| Measure |
Atomoxetine
n=105 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity
Baseline
|
5.1 units on a scale
Standard Deviation 0.8
|
5.1 units on a scale
Standard Deviation 0.9
|
|
Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity
Change to 8 Week Endpoint
|
-0.6 units on a scale
Standard Deviation 0.7
|
0.0 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.
Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.
Outcome measures
| Measure |
Atomoxetine
n=105 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale
Change to 8 Week Endpoint
|
-2.7 units on a scale
Standard Deviation 4.1
|
-0.3 units on a scale
Standard Deviation 2.6
|
|
Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale
Baseline
|
17.2 units on a scale
Standard Deviation 3.0
|
17.5 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.
The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety.
Outcome measures
| Measure |
Atomoxetine
n=103 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
Change to 8 Week Endpoint
|
-2.1 units on a scale
Standard Deviation 7.6
|
-1.7 units on a scale
Standard Deviation 6.5
|
|
Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
Baseline
|
20.3 units on a scale
Standard Deviation 11.8
|
18.8 units on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.
Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.
Outcome measures
| Measure |
Atomoxetine
n=105 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised
Baseline
|
28.0 units on a scale
Standard Deviation 8.4
|
26.9 units on a scale
Standard Deviation 8.1
|
|
Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised
Change to 8 Week Endpoint
|
-0.5 units on a scale
Standard Deviation 4.4
|
-0.1 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.
A 27-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.
Outcome measures
| Measure |
Atomoxetine
n=103 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
Hyperactivity Baseline
|
12.0 units on a scale
Standard Deviation 3.8
|
12.0 units on a scale
Standard Deviation 4.0
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
Hyperactivity Change to 8 Week Endpoint
|
-2.2 units on a scale
Standard Deviation 4.1
|
-0.7 units on a scale
Standard Deviation 2.6
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
ADHD Index Baseline
|
28.2 units on a scale
Standard Deviation 4.9
|
28.4 units on a scale
Standard Deviation 5.2
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
ADHD Index Change to 8 Week Endpoint
|
-5.0 units on a scale
Standard Deviation 6.7
|
-0.1 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
Oppositional Baseline
|
11.7 units on a scale
Standard Deviation 3.8
|
12.2 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
Oppositional Change to 8 Week Endpoint
|
-1.2 units on a scale
Standard Deviation 3.9
|
0.8 units on a scale
Standard Deviation 2.7
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
Cognitive Problems Baseline
|
14.3 units on a scale
Standard Deviation 3.1
|
14.2 units on a scale
Standard Deviation 3.2
|
|
Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
Cognitive Problems Change to 8 Week Endpoint
|
-2.3 units on a scale
Standard Deviation 3.8
|
0.2 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=\[(score-4.2382)\*10/0.32835\] + 50. Higher scores mean improvement.
Outcome measures
| Measure |
Atomoxetine
n=97 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=29 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form
Baseline
|
27.1 standard deviation units
Standard Deviation 10.4
|
26.9 standard deviation units
Standard Deviation 11.2
|
|
Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form
Change to 8 Week Endpoint
|
3.6 standard deviation units
Standard Deviation 8.0
|
1.2 standard deviation units
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)Population: Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.
A 28-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
Outcome measures
| Measure |
Atomoxetine
n=58 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=18 Participants
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
Oppositional Change to 8 Week Endpoint
|
-1.1 units on a scale
Standard Deviation 2.9
|
0.1 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
Cognitive Problems Baseline
|
8.2 units on a scale
Standard Deviation 4.3
|
8.5 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
Cognitive Problems Change to 8 Week Endpoint
|
-0.9 units on a scale
Standard Deviation 2.5
|
0.0 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
Hyperactivity Baseline
|
12.8 units on a scale
Standard Deviation 5.5
|
16.3 units on a scale
Standard Deviation 3.4
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
Hyperactivity Change to 8 Week Endpoint
|
-2.1 units on a scale
Standard Deviation 4.7
|
-1.1 units on a scale
Standard Deviation 3.0
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
ADHD Index Baseline
|
25.3 units on a scale
Standard Deviation 8.4
|
29.4 units on a scale
Standard Deviation 6.0
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
ADHD Index Change to 8 Week Endpoint
|
-3.5 units on a scale
Standard Deviation 7.1
|
-0.9 units on a scale
Standard Deviation 3.3
|
|
Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
Oppositional Baseline
|
7.6 units on a scale
Standard Deviation 4.3
|
10.8 units on a scale
Standard Deviation 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approvalPopulation: Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.
Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.
Outcome measures
| Measure |
Atomoxetine
n=124 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Open-Label Phase Serious Adverse Events
Vomiting
|
1 participants
|
—
|
|
Open-Label Phase Serious Adverse Events
Infectious mononucleosis
|
1 participants
|
—
|
|
Open-Label Phase Serious Adverse Events
Agitation
|
1 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approvalPopulation: Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.
Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.
Outcome measures
| Measure |
Atomoxetine
n=124 Participants
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Open-Label Phase Nonserious Adverse Events
Abdominal pain
|
6 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Nausea
|
10 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Vomiting
|
11 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Pyrexia
|
6 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Influenza
|
7 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Weight decreased
|
5 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Anorexia
|
10 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Decreased appetite
|
7 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Agitation
|
7 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Insomnia
|
4 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Headache
|
19 participants
|
—
|
|
Open-Label Phase Nonserious Adverse Events
Somnolence
|
8 participants
|
—
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=107 participants at risk
atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
Placebo
n=32 participants at risk
placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
11/107 • Number of events 13 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
3.1%
1/32 • Number of events 1 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.4%
9/107 • Number of events 11 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
12.5%
4/32 • Number of events 4 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
4/107 • Number of events 6 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
6.2%
2/32 • Number of events 2 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Gastrointestinal disorders
Nausea
|
13.1%
14/107 • Number of events 15 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
0.00%
0/32 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
14/107 • Number of events 22 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
3.1%
1/32 • Number of events 1 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Infections and infestations
Influenza
|
8.4%
9/107 • Number of events 9 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
0.00%
0/32 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Investigations
Weight decreased
|
5.6%
6/107 • Number of events 6 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
0.00%
0/32 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Metabolism and nutrition disorders
Anorexia
|
24.3%
26/107 • Number of events 27 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
3.1%
1/32 • Number of events 1 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.4%
9/107 • Number of events 10 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
0.00%
0/32 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Nervous system disorders
Headache
|
16.8%
18/107 • Number of events 22 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
12.5%
4/32 • Number of events 5 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Nervous system disorders
Somnolence
|
16.8%
18/107 • Number of events 19 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
6.2%
2/32 • Number of events 2 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Psychiatric disorders
Nervousness
|
5.6%
6/107 • Number of events 6 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
3.1%
1/32 • Number of events 2 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/107 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
6.2%
2/32 • Number of events 2 • The results in this module are serious (there weren't any) and non-serious adverse events during Study Period III. Adverse events during the Open-Label (Period IV) phase are presented as Other Pre-Specified Outcome Measures.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60