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| Sponsor: | Ortho-McNeil Janssen Scientific Affairs, LLC |
|---|---|
| Information provided by: | Ortho-McNeil Janssen Scientific Affairs, LLC |
| ClinicalTrials.gov Identifier: | NCT00978328 |
Purpose
The purpose of this study is to describe clinical and demographic characteristics of patients receiving prescription medications containing oxycodone immediate release (OXYRX), to characterize patient and prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment, to describe prescriber decision-making about pain management with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain medications.
| Condition | Intervention |
|---|---|
|
Pain |
Drug: oxycodone immediate release (OXYRX) |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain |
| Estimated Enrollment: | 800 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | January 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
001
oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX
|
Drug: oxycodone immediate release (OXYRX)
Characteristics of pts. receiving prescription medications containing OXYRX
|
Real-world utility of Schedule II immediate release opioids depends on both efficacy and side effects. Few existing data sources systematically captured opioid-related side effects and their impact on patient outcomes and physician practice. This study is expected to lead to an in-depth understanding of patient and prescriber perceptions of both effectiveness and side effects associated with medications containing the most widely prescribed oral Schedule II immediate release opioid for pain management, oxycodone immediate release (OXYRX), alone (eg, Roxicodone®) or in combination (eg, Percocet®, Tylox®) in actual clinical practice. This is a prospective, multi-center, observational patient registry. Adult outpatients who have pain due to a non-cancerous condition meeting study eligibility will be enrolled. Prescribers will treat patients according to their usual practice. Prescribers will treat patients, meeting study eligibility, with OXYRX according to their usual practice.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients presenting for treatment of a painful condition with a Schedule II opioid at an outpatient setting will be potential candidates for enrollment for this registry.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Show 57 Study Locations| Study Director: | Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial | Ortho-McNeil Janssen Scientific Affairs, LLC |
More Information
| Responsible Party: | ( Vice President, Medical Affairs, Internal Medicine ) |
| Study ID Numbers: | CR015670 |
| Study First Received: | September 15, 2009 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00978328 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Pain conditions Oxycodone immediate release Percocet®, Tylox® Roxicodone® |
Registry Side effects Observational Pain management |
|
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Oxycodone Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |