An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT01060150, Phase 4, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-07-31
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD) | ClinicalTrials.gov |
| NCT number | NCT01060150 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 115 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Janssen Korea, Ltd., Korea | ClinicalTrials.gov |
| Conditions | Attention Deficit Disorder With Hyperactivity | ClinicalTrials.gov |
| Interventions | OROS Methylphenidate HCl | ClinicalTrials.gov |
| First posted | 2010-02-02 | ClinicalTrials.gov |
| Last updated | 2013-08-23 | ClinicalTrials.gov |
| Results first posted | 2013-07-31 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score | Week 12 | The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition. | ClinicalTrials.gov |
| Primary | Clinical Global Impression - Severity (CGI-S) Score | Week 12 | 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 scores indicate worsening. | ClinicalTrials.gov |
| Primary | Clinical Global Impression - Improvement (CGI-I) Score | Week 12 | 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. | ClinicalTrials.gov |
| Primary | Learning Skill Test (LST) Total Score | Week 12 | The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning. | ClinicalTrials.gov |
| Secondary | Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors | Baseline and Week 12 | The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention. | ClinicalTrials.gov |
| Secondary | Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability | Baseline and Week 12 | The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit. | ClinicalTrials.gov |
| Secondary | Digit Span Test Score | Baseline and Week 12 | Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention. | ClinicalTrials.gov |
| Secondary | Finger Window (FW) Test Score | Baseline and Week 12 | In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state. | ClinicalTrials.gov |
| Secondary | Controlled Oral Words Association Test (COWAT) Score | Baseline and Week 12 | This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency. | ClinicalTrials.gov |
| Secondary | Stroop Test Result for Reaction Time | Baseline and Week 12 | This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation. | ClinicalTrials.gov |
| Secondary | Stroop Test Result for False Reaction | Baseline and Week 12 | This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention. | ClinicalTrials.gov |
| Secondary | Stroop Test Score for Ratio Interference | Baseline and Week 12 | Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation. | ClinicalTrials.gov |
Outcomes 12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score | Week 12 | Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF). | Units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Clinical Global Impression - Severity (CGI-S) Score | Week 12 | ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF. | Units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Clinical Global Impression - Improvement (CGI-I) Score | Week 12 | ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Learning Skill Test (LST) Total Score | Week 12 | ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | T-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Errors | MEAN | ClinicalTrials.gov |
| SECONDARY | Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Units on scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Digit Span Test Score | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Finger Window (FW) Test Score | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Controlled Oral Words Association Test (COWAT) Score | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Words | MEAN | ClinicalTrials.gov |
| SECONDARY | Stroop Test Result for Reaction Time | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Stroop Test Result for False Reaction | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Errors | MEAN | ClinicalTrials.gov |
| SECONDARY | Stroop Test Score for Ratio Interference | Baseline and Week 12 | The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Units on a scale | MEAN | ClinicalTrials.gov |
Results by group 38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score | OROS Methylphenidate HCl | 11.78 | Standard Deviation 7.64 | Units on a scale | ClinicalTrials.gov | |
| Clinical Global Impression - Severity (CGI-S) Score | OROS Methylphenidate HCl | 2.81 | Standard Deviation 1.12 | Units on a scale | ClinicalTrials.gov | |
| Clinical Global Impression - Improvement (CGI-I) Score | OROS Methylphenidate HCl | 2.14 | Standard Deviation 0.75 | Units on a scale | ClinicalTrials.gov | |
| Learning Skill Test (LST) Total Score | OROS Methylphenidate HCl | 49.61 | Standard Deviation 11.57 | T-score | ClinicalTrials.gov | |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors | OROS Methylphenidate HCl | Omission errors: Baseline | 58.88 | Standard Deviation 27.35 | Errors | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors | OROS Methylphenidate HCl | Omission errors: Week 12 | 57.40 | Standard Deviation 48.79 | Errors | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors | OROS Methylphenidate HCl | Commission errors: Baseline | 62.98 | Standard Deviation 32.32 | Errors | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors | OROS Methylphenidate HCl | Commission errors: Week 12 | 51.70 | Standard Deviation 21.19 | Errors | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability | OROS Methylphenidate HCl | Reaction time average: Baseline | 54.32 | Standard Deviation 15.45 | Units on scale | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability | OROS Methylphenidate HCl | Reaction time average: Week 12 | 49.73 | Standard Deviation 26.33 | Units on scale | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability | OROS Methylphenidate HCl | Response variability: Baseline | 85.77 | Standard Deviation 60.21 | Units on scale | ClinicalTrials.gov |
| Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability | OROS Methylphenidate HCl | Response variability: Week 12 | 59.42 | Standard Deviation 64.77 | Units on scale | ClinicalTrials.gov |
| Digit Span Test Score | OROS Methylphenidate HCl | Forward: Baseline | 11.19 | Standard Deviation 2.92 | Units on a scale | ClinicalTrials.gov |
| Digit Span Test Score | OROS Methylphenidate HCl | Forward: Week 12 | 11.56 | Standard Deviation 2.90 | Units on a scale | ClinicalTrials.gov |
| Digit Span Test Score | OROS Methylphenidate HCl | Backward: Baseline | 7.09 | Standard Deviation 2.39 | Units on a scale | ClinicalTrials.gov |
| Digit Span Test Score | OROS Methylphenidate HCl | Backward: Week 12 | 7.32 | Standard Deviation 2.41 | Units on a scale | ClinicalTrials.gov |
| Finger Window (FW) Test Score | OROS Methylphenidate HCl | Forward FW: Baseline | 18.42 | Standard Deviation 4.60 | Units on a scale | ClinicalTrials.gov |
| Finger Window (FW) Test Score | OROS Methylphenidate HCl | Forward FW: Week 12 | 19.09 | Standard Deviation 4.49 | Units on a scale | ClinicalTrials.gov |
| Finger Window (FW) Test Score | OROS Methylphenidate HCl | Backward FW: Baseline | 15.59 | Standard Deviation 4.97 | Units on a scale | ClinicalTrials.gov |
| Finger Window (FW) Test Score | OROS Methylphenidate HCl | Backward FW: Week 12 | 17.36 | Standard Deviation 3.84 | Units on a scale | ClinicalTrials.gov |
Participant flow 4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | OROS Methylphenidate HCl | 115 | ClinicalTrials.gov | |
| Overall Study | Treated | OROS Methylphenidate HCl | 113 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | OROS Methylphenidate HCl | 92 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | OROS Methylphenidate HCl | 23 | ClinicalTrials.gov |
Adverse events 21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Decreased appetite | Metabolism and nutrition disorders | OROS Methylphenidate HCl | 66 | 113 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | OROS Methylphenidate HCl | 32 | 113 | ClinicalTrials.gov | |
| other | Abdominal pain upper | Gastrointestinal disorders | OROS Methylphenidate HCl | 19 | 113 | ClinicalTrials.gov | |
| other | Stomach discomfort | Gastrointestinal disorders | OROS Methylphenidate HCl | 15 | 113 | ClinicalTrials.gov | |
| other | Vomiting | Gastrointestinal disorders | OROS Methylphenidate HCl | 7 | 113 | ClinicalTrials.gov | |
| other | Diarrhoea | Gastrointestinal disorders | OROS Methylphenidate HCl | 6 | 113 | ClinicalTrials.gov | |
| other | Insomnia | Psychiatric disorders | OROS Methylphenidate HCl | 37 | 113 | ClinicalTrials.gov | |
| other | Anxiety | Psychiatric disorders | OROS Methylphenidate HCl | 9 | 113 | ClinicalTrials.gov | |
| other | Depression | Psychiatric disorders | OROS Methylphenidate HCl | 9 | 113 | ClinicalTrials.gov | |
| other | Nervousness | Psychiatric disorders | OROS Methylphenidate HCl | 7 | 113 | ClinicalTrials.gov | |
| other | Anger | Psychiatric disorders | OROS Methylphenidate HCl | 6 | 113 | ClinicalTrials.gov | |
| other | Headache | Nervous system disorders | OROS Methylphenidate HCl | 31 | 113 | ClinicalTrials.gov | |
| other | Dizziness | Nervous system disorders | OROS Methylphenidate HCl | 11 | 113 | ClinicalTrials.gov | |
| other | Somnolence | Nervous system disorders | OROS Methylphenidate HCl | 8 | 113 | ClinicalTrials.gov | |
| other | Irritability | General disorders | OROS Methylphenidate HCl | 16 | 113 | ClinicalTrials.gov | |
| other | Fatigue | General disorders | OROS Methylphenidate HCl | 13 | 113 | ClinicalTrials.gov | |
| other | Nasopharyngitis | Infections and infestations | OROS Methylphenidate HCl | 19 | 113 | ClinicalTrials.gov | |
| other | Palpitations | Cardiac disorders | OROS Methylphenidate HCl | 8 | 113 | ClinicalTrials.gov | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | OROS Methylphenidate HCl | 6 | 113 | ClinicalTrials.gov | |
| serious | Lymphadenitis | Blood and lymphatic system disorders | OROS Methylphenidate HCl | 1 | 113 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | OROS Methylphenidate HCl | ClinicalTrials.gov | ||
| Total, other adverse events | OROS Methylphenidate HCl | 98 | 113 | ClinicalTrials.gov |
| Total, serious adverse events | OROS Methylphenidate HCl | 2 | 113 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 23587983 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)