Attention Deficit Disorder With HyperactivityPhase 4NCT00758160
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4 study testing OROS Methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by Johnson & Johnson Taiwan Ltd.
Trial summary
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- OROS Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants who are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Participants who have been treated with Immediate-release methyphenidate (IR-MPH) for at least 4 weeks before enrollment, but previous treatment is considered unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons
- Participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol-specified assessments
- Participants who are still at school
- Participants who are treated with greater than equal to 10 milligram (mg) IR-MPH daily before enrollment
Who cannot join
- Participants who cannot understand or follow the instructions given in the study
- Participants with serious or unstable medical illness
- Participants who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
- Participants who have glaucoma (increased pressure inside the eye that causes visual problems), an ongoing seizure disorders, or a psychotic disorder
- Participants who are hypersensitive to methylphenidate
- Participants who have any co-existing medical condition or are taking a concomitant medication that is likely to interfere with safe administration of methylphenidate
About this study
Official title: From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).
Read the detailed description
This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.
- Being tested
- OROS Methylphenidate
- Keywords
- Attention Deficit Disorder With Hyperactivity, Methylphenidate, Concerta
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS MethylphenidateDrug
Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
| Study group | Role | What they receive |
|---|---|---|
| OROS methylphenidate | Experimental | Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects. Receives: Drug: OROS Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
Measured: Baseline and Week 2
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.
Measured: Baseline and Week 4
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.
Measured: Baseline and Week 8
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.
Measured: Baseline and Week 4
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.
Measured: Baseline and Week 8
Secondary outcomes (6)
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.
Measured: Baseline, Week 4 and 8
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.
Measured: Baseline, Week 2, 4 and 8
Social Adjustment Scale Score for Children and Adolescents (SAICA)
SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.
Measured: Baseline, Week 4 and Week 8
Clinical Global Impression-Severity (CGI-S) Score
CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.
Measured: Baseline, Week 2, 4 and 8
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).
Measured: Baseline, Week 2, 4 and 8
Global Assessment of Satisfaction by Parents/Caregivers
Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.
Measured: Baseline, Week 2, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758160
- Sponsor's protocol ID
- CR015331
- Other IDs
- CONCERTAATT4086, CCT-TWN-MA6
- Status last verified
- Mar 2014
- First submitted
- 19 Sep 2008
- Last updated
- 8 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT00758160
- Acronym / sponsor ID
- CR015331
- Keywords
- Attention Deficit Disorder With Hyperactivity, Methylphenidate, Concerta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Posted 8 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).
Detailed description
This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OROS methylphenidate | Experimental | Drug: OROS MethylphenidateParticipants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants who are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Participants who have been treated with Immediate-release methyphenidate (IR-MPH) for at least 4 weeks before enrollment, but previous treatment is considered unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons
- Participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol-specified assessments
- Participants who are still at school
- Participants who are treated with greater than equal to 10 milligram (mg) IR-MPH daily before enrollment
Key exclusion criteria (6 listed)
- Participants who cannot understand or follow the instructions given in the study
- Participants with serious or unstable medical illness
- Participants who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
- Participants who have glaucoma (increased pressure inside the eye that causes visual problems), an ongoing seizure disorders, or a psychotic disorder
- Participants who are hypersensitive to methylphenidate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OROS MethylphenidateParticipants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects. | Drug | OROS methylphenidate |
Primary outcome
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Time frame: Baseline and Week 2
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Time frame: Baseline and Week 4
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Time frame: Baseline and Week 8
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Time frame: Baseline and Week 4
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
Time frame: Baseline and Week 8
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.
6 secondary outcomes
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Time frame: Baseline, Week 4 and 8
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Time frame: Baseline, Week 2, 4 and 8
Social Adjustment Scale Score for Children and Adolescents (SAICA)
Time frame: Baseline, Week 4 and Week 8
Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline, Week 2, 4 and 8
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Time frame: Baseline, Week 2, 4 and 8
Global Assessment of Satisfaction by Parents/Caregivers
Time frame: Baseline, Week 2, 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OROS Methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by Johnson & Johnson Taiwan Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 (time frame: Baseline and Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.