tapentadol IR
DrugOpioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
NCT Number: NCT01545778
The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate release with the risk of shopping behavior of oxycodone immediate release.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
This is a retrospective (a study that looks backward in time, usually using medical records and interviews with patients) matched cohort (designated group followed or traced over a period of time) study using IMS LRx database. This database covers 65% of all retail prescriptions in the United States and includes mail service and specialty pharmacy provider prescriptions independent of the method of payment. The study will include Opioid naive patients exposed to tapentadol immediate release (IR) or oxycodone IR from July 2009 to December 2010. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. Patients will be followed for 1 year from their index dates. Each tapentadol IR-exposed patient will be matched to up to 4 oxycodone IR-exposed patients. Matching will allow to control in the design for potential confounding variables such as time of the exposure, geographic area, specialty of the prescriber, and age. These are variables that have been related with the risk of shopping behavior or abuse.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
The type of dispensing in the shopping event will be classified as "Only the indexed opioid" "Indexed opioid was involved", or "Indexed opioid was not involved at all".
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01037569
Substance Abuse Detection
Davis, California, United States
View Trial DetailsNCT01124591
Blood-Borne Infections, Brief Intervention
Providence, Rhode Island, United States
View Trial DetailsNCT07549126
Chemically-Induced Disorders, Clinical Decision Support
Guilford, Connecticut, United States
View Trial DetailsNCT07737652
Anxiety, Anxiety Disorders
Tuscaloosa, Alabama, United States
View Trial Details