Oxycodone User Registry (OUR)

This study has been completed.
Sponsor:
Information provided by:
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00978328
First received: September 15, 2009
Last updated: April 1, 2010
Last verified: April 2010
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Describe clinical / demographic characteristics of patients receiving OXYRX; characterize patient / prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment; describe prescriber decision-making about pain meds [ Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28 ] [ Designated as safety issue: No ]

Enrollment: 827
Study Start Date: June 2009
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

Detailed Description:

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
Study Population

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.

Criteria

Inclusion Criteria:

  • Pain requiring treatment with a Schedule II immediate release opioid within 3 days following the baseline visit
  • and pain that warrants treatment with a prescription for OXYRX PRN (alone or in combination) for at least 5 days after the baseline visit

Exclusion Criteria:

  • Use of any Schedule II opioid within 30 days prior to informed consent
  • planned use of other opioids (Schedule II-V) while using OXYRX
  • malignancy other than superficial skin cancers (ie, basal cell, squamous cell) within the past year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978328

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

No publications provided

Responsible Party: Vice President, Medical Affairs, Internal Medicine
ClinicalTrials.gov Identifier: NCT00978328     History of Changes
Other Study ID Numbers: CR015670
Study First Received: September 15, 2009
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Pain conditions
Oxycodone immediate release
Percocet®, Tylox®
Roxicodone®
Registry
Side effects
Observational
Pain management

Additional relevant MeSH terms:
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 22, 2014