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Terminated Phase 4 Interventional Results available

Open-Label Trial Comparing Oxycodone Medications

ClinicalTrials.gov ID: NCT01162304

Public ClinicalTrials.gov record NCT01162304. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) medication as they need to control their pain. In addition, the ability to vary the medication doses in this way will give them a greater sense of control, which will also contribute to greater pain relief. Similarly, the investigators predict that patients will show greater benefits with IR-oxycodone on the measures of physical and emotional functioning. Because there is relatively little data on sleep apnea in chronic pain patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based. Finally, although it is typically thought that the abuse liability of IR-opioid medications is greater than for ER-medications, the data on which this belief are based have not involved systematic studies of patients with chronic pain; the assessments of abuse liability will therefore also be exploratory.

Study identification

NCT ID
NCT01162304
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
University of Rochester
Other
Enrollment
18 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2010
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013
Last update posted
Jul 16, 2015

2010 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Rochester Medical Center Rochester New York 14642

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01162304, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2015 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01162304 live on ClinicalTrials.gov.

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