NCT02730572

Concerta (Methylphenidate) -To-Generic Switch Study

Concerta-to-Generic Switch Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,464 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

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

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-04-06
• Last updated: 2017-02-13