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Trial record 4 of 439 for:    Methylphenidate

Concerta (Methylphenidate) -To-Generic Switch Study

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ClinicalTrials.gov Identifier: NCT02730572
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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. 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.

Condition or disease Intervention/treatment
Attention Deficit Disorder With Hyperactivity Drug: Concerta Drug: Concerta AG formulation Drug: Concerta EG formulation

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).

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Study Type : Observational
Actual Enrollment : 1464 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Concerta-to-Generic Switch Study
Study Start Date : September 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Group/Cohort Intervention/treatment
Concerta to authorized generic (AG) formulation
Participants 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.
Drug: Concerta
This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.
Other Name: Methylphenidate

Drug: Concerta AG formulation
This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed.
Other Name: Methylphenidate

Concerta to equivalent generic (EG) formulation
Participants 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.
Drug: Concerta
This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.
Other Name: Methylphenidate

Drug: Concerta EG formulation
This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed.
Other Name: Methylphenidate




Primary Outcome Measures :
  1. 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) ]
  2. Number of Participants Changing the use of Immediate Release (IR) Methylphenidate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG) ]

Secondary Outcome Measures :
  1. Number of Participants Changing the use of Immediate Release (IR) Methylphenidate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 60 days after the index date (the date when participant switches from Concerta to an AG or EG) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730572


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02730572     History of Changes
Other Study ID Numbers: CR107709
RRA 14797 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Janssen Research & Development, LLC:
Attention Deficit Hyperactivity Disorder
Methylphenidate
Additional relevant MeSH terms:
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Methylphenidate
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents