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Trial record 81 of 683 for:    OXYCODONE

Oxycodone User Registry (OUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00978328
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : April 2, 2010
Sponsor:
Information provided by:
Ortho-McNeil Janssen Scientific Affairs, LLC

Tracking Information
First Submitted Date September 15, 2009
First Posted Date September 16, 2009
Last Update Posted Date April 2, 2010
Study Start Date June 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 18, 2009)
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 ]
Original Primary Outcome Measures
 (submitted: September 15, 2009)
  • Describe clinical/demographic characteristics of patients receiving OXYRX [ Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28 ]
  • Characterize patient/prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment [ Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28 ]
  • Describe prescriber decision-making about pain medications [ Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oxycodone User Registry (OUR)
Official Title A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pain
Intervention Drug: oxycodone immediate release (OXYRX)
Characteristics of pts. receiving prescription medications containing OXYRX
Study Groups/Cohorts 001
oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX
Intervention: Drug: oxycodone immediate release (OXYRX)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 1, 2010)
827
Original Estimated Enrollment
 (submitted: September 15, 2009)
800
Actual Study Completion Date January 2010
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00978328
Other Study ID Numbers CR015670
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vice President, Medical Affairs, Internal Medicine
Study Sponsor Ortho-McNeil Janssen Scientific Affairs, LLC
Collaborators Not Provided
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
PRS Account Ortho-McNeil Janssen Scientific Affairs, LLC
Verification Date April 2010