Concerta (Methylphenidate) -To-Generic Switch Study

NCT02730572 | Completed

• 2 other identifiers: CR107709RRA 14797
• Study Type: observational
• Target: 1,464
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; Methylphenidate

Outcome Measures

Primary Outcomes (4)

• Number of Participants Switching Back to Concerta

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

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

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

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

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

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

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

Secondary Outcomes (4)

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

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

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

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

• Number of Participants Changing an Established Methylphenidate

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

• Number of Participants Having Outpatient Visits for ADHD

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

Study Arms (2)

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; Drug: Concerta AG formulation

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; Drug: Concerta EG formulation

Interventions

Concerta DRUG

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

Also known as: Methylphenidate

Concerta to authorized generic (AG) formulation; Concerta to equivalent generic (EG) formulation

Concerta AG formulation DRUG

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

Also known as: Methylphenidate

Concerta to authorized generic (AG) formulation

Concerta EG formulation DRUG

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

Also known as: Methylphenidate

Concerta to equivalent generic (EG) formulation

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Related Publications (1)

• 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.

  PMID: 29489906 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 6, 2016
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 13, 2017

Record last verified: 2017-02