Clinical Trial Results:
An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children with ADHD (FOSCO)
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Summary
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EudraCT number |
2015-001217-27 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
07 Aug 2009
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Results information
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Results version number |
v2(current) |
This version publication date |
01 Jul 2016
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First version publication date |
05 Aug 2015
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CONCERTAATT4092
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01012622 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Research and Development
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Sponsor organisation address |
Archimedesweg 29, Leiden, Netherlands, 2333CM
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Public contact |
Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Aug 2009
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Aug 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study was to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD)."
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Protection of trial subjects |
The safety assessments included the incidence and severity of Adverse events ( AEs), Clinical laboratory assessments, vital signs, physical examinations and Adverse events were assessed throughout the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Aug 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Korea, Republic of: 136
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Worldwide total number of subjects |
136
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
133
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Adolescents (12-17 years) |
3
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 142 participants were enrolled in the study, out of which 136 participants receieved atleast one dose of study drug. Among them, 111 participants completed the study and 31 participants were withdrawn from the study. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Concerta | ||||||||||||||||||
Arm description |
OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
CONCERTA
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants were administered Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCL) was given orally once daily at a maximum maintenance dose of 54 milligram (mg) orally once daily up to Week 12.
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Baseline characteristics reporting groups
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Reporting group title |
Concerta
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Reporting group description |
OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Concerta
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Reporting group description |
OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability. | ||
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End point title |
Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12 [1] | ||||||||||||
End point description |
K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. Intention-to-treat (ITT) population included participants who received the study drug at least once and had the primary efficacy endpoint data available.
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End point type |
Primary
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End point timeframe |
Baseline and Week 12
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants With Response Based on K-ARS Total Score at Week 12 [2] | ||||||
End point description |
Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Week 12
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed |
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End point title |
Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression – Improvement (CGI-I) Scale Score at Week 12 [3] | ||||||
End point description |
Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) “Very much improved” or “Much improved” in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1= very much improved; 2= much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse, higher score indicates worsening of condition. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Week 12
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed |
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End point title |
Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12 | ||||||||||||||||||||||||||||||||
End point description |
Child Health and Illness Profile-Child Edition (CHIP) was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health. ITT population included participants who took study drug at least once and had primary efficacy endpoint data available. Last Observation Carried Forward (LOCF) method was used. "n" signifies participants who were evaluated for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 | ||||||||||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 | ||||||||||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 | ||||||||||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 | ||||||||||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12 | ||||||||||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12 | ||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants were evaluable.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12 | ||||||||||||||||
End point description |
CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants were evaluable.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12 | ||||||||||||
End point description |
APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12 | ||||||||||||
End point description |
Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12 | ||||||||||||
End point description |
Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from ”never” to “very truly”. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12 | ||||||||||||
End point description |
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12 | ||||||||||
End point description |
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation. ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From signing of informed consent form until 30 days from the completion of assessments after the administration of the last study medication (follow-up) or the point of time of dropout.
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Adverse event reporting additional description |
Safety population included all participants who took at least one dose of study drug.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Concerta
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Reporting group description |
OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
