Oxycodone User Registry (OUR)

NCT00978328 | Completed

• 1 other identifier: CR015670
• Study Type: observational
• Target: 827
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain

Keywords

Pain conditions; Oxycodone immediate release; Percocet®, Tylox®; Roxicodone®; Registry; Side effects; Observational; Pain management

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28

Study Arms (1)

001

oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX

Drug: oxycodone immediate release (OXYRX)

Interventions

oxycodone immediate release (OXYRX) DRUG

Characteristics of pts. receiving prescription medications containing OXYRX

001

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: June 1, 2009
• Study Completion: January 1, 2010
• Last Updated: April 2, 2010

Record last verified: 2010-04