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Attention Deficit Disorder With HyperactivityNCT02730572

Concerta (Methylphenidate) -To-Generic Switch Study

An observational study of Attention Deficit Disorder With Hyperactivity, run by Janssen Research & Development, LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to identify whether, after adjustment for confounders via stratification on a propensity score and adjustment for calendar year, the combined endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of immediate release [IR] methylphenidate, 3. Read more about this study

Who is it for?
Ages 6 to 65 years
What is being tested?
Concerta, Concerta AG formulation and Concerta EG formulation
How many people
1,464 participants
Where
No sites listed yet
Study dates
Sep 2015to Oct 2016
Phase
Observational
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in the study will have a confirmed diagnosis of ADHD and continuously used Concerta brand of methylphenidate for at least 60 days and receive a dispensing of the AG or EG formulation within 15 days of the end of the days of Concerta supplied.

Who may be able to join

  • Male or female participants 6 to 65 years of age
  • Have been in the database continuously for at least 183 days after June 1, 2012
  • Have a diagnosis of attention deficit hyperactivity disorder (ADHD)
  • Use Concerta (a brand of methylphenidate) for at least 60 days and receive a dispensing of the authorized generic (AG) or equivalent generic (EG) formulation within 15 days of the end of the days of Concerta supplied. The date of that dispensing of the EG or AG formulation is the participants index date
  • Have an index date greater than or equal to (>=) Dec 1, 2012 and less than or equal to (<=) Dec 3, 2014, the former to reflect the fact that the EG preparation became available in December, 2012, and the latter to allow 60 days follow up <= Jan 31, 2015, which is the end date for the available data

Who cannot join

  • Their age or sex is not specified in the database
  • At any time after June 1, 2012 and before their index date they receive a diagnosis of Renal insufficiency or Hepatic insufficiency or Schizophrenia or Bipolar disorder or mania or Anxiety or Glaucoma or Tourettes's syndrome or Nervous tension or Narrowing of esophagus, stomach or intestine
  • At any time from 183 days before they join the cohort to 60 days after their index date, they a) are diagnosed as pregnant; b) are dispensed any prescription medication commonly used to treat seizures or migraines c) are dispensed any antidepressant or antipsychotic medication
  • At any time from 60 days before their index date to 60 days after their index date they a) Receive a dispensing of methylphenidate in any form other than a non-chewable tablet, example, if they receive methylphenidate as a patch, suspension, syrup, or chewable tablet b) Receive a dispensing of long acting (LA) methylphenidate other than Concerta, the AG formulation or an EG formulation
  • Concerta is dispensed to the participant <= 3 days after the index date

About this study

Official title: Concerta-to-Generic Switch Study

The primary purpose of this study is to identify whether, after adjustment for confounders via stratification on a propensity score and adjustment for calendar year, the combined endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of immediate release [IR] methylphenidate, 3. beginning a new attention deficit hyperactivity disorder [ADHD] medication, or 4. stopping both Concerta and the long acting [LA] methylphenidate {authorized generic [AG] methylphenidate or equivalent generic [EG] methylphenidate} that was begun on the index date), differs between participants who switch from branded Concerta to the EG formulations versus participants who switch from branded Concerta to the AG formulation.

Read the detailed description

This is a retrospective cohort study based on a health claims database, the Truven Commercial Claims and Encounters (CCAE) database. Participants will enter the cohort when, after using Concerta continuously for at least 60 days after October 3, 2012, they receive a dispensing of the AG or EG formulation within 15 days of the end of the days of Concerta supplied. The date of that dispensing of the AG or EG formulation is the participants index date. This study will track various events, example, back-switches, and methylphenidate dose changes over time (the 60 days before the switch from Concerta to an AG or EG generic compared to the 60 days after that switch).

Being tested
Concerta, Concerta AG formulation, Concerta EG formulation
Keywords
Attention Deficit Hyperactivity Disorder, Methylphenidate
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.

  • ConcertaDrug

    Also called Methylphenidate

    This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.

  • Concerta AG formulationDrug

    Also called Methylphenidate

    This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed.

  • Concerta EG formulationDrug

    Also called Methylphenidate

    This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed.

Study groups in NCT02730572
Study groupRoleWhat they receive
Concerta to authorized generic (AG) formulationParticipants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in the study will have a confirmed diagnosis of ADHD and continuously using Concerta for at least 60 days. Participants who will switch from Concerta to AG formulation will be observed.
Receives: Drug: Concerta; Drug: Concerta AG formulation
Concerta to equivalent generic (EG) formulationParticipants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in the study will have a confirmed diagnosis of ADHD and continuously using Concerta for at least 60 days. Participants who will switch from Concerta to EG formulation will be observed.
Receives: Drug: Concerta; Drug: Concerta EG formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Switching Back to Concerta

    Measured: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)

  2. Number of Participants Changing the use of Immediate Release (IR) Methylphenidate

    Measured: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)

  3. Number of Participants Starting a new Different Attention Deficit Hyperactivity Disorder (ADHD) Medication

    Measured: 60 Days before index date (the date when participant switches from Concerta to an AG or EG)

  4. Number of Participants Discontinuing the use of Both Concerta and the Study Drug to Which the Participant is Switched

    Measured: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)

Secondary outcomes (4)

  1. Number of Participants Changing the use of Immediate Release (IR) Methylphenidate

    Measured: 60 Days before and after index (the date when participant switches from Concerta to an AG or EG)

  2. Number of Participants Starting a new Different Attention Deficit Hyperactivity Disorder (ADHD) Medication

    Measured: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)

  3. Number of Participants Changing an Established Methylphenidate

    Measured: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)

  4. Number of Participants Having Outpatient Visits for ADHD

    Measured: 60 days after the index date (the date when participant switches from Concerta to an AG or EG)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730572
Sponsor's protocol ID
CR107709
Other IDs
RRA 14797
Status last verified
Feb 2017
First submitted
1 Apr 2016
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Fife D, Cepeda MS, Baseman A, Richards H, Hu P, Starr HL, Sena AG. Medication changes after switching from CONCERTA(R) brand methylphenidate HCl to a generic long-acting formulation: A retrospective database study. PLoS One. 2018 Feb 28;13(2):e0193453. doi: 10.1371/journal.pone.0193453. eCollection 2018.

    PubMed 29489906

Questions about this trial

What is this clinical trial studying?

An observational study of Attention Deficit Disorder With Hyperactivity, run by Janssen Research & Development, LLC.

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 5 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 13 Feb 2017. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants Switching Back to Concerta (time frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730572, which also lists 1 linked publication.

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 13 Feb 2017.

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