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Open-Label Trial Comparing Oxycodone Medications

NCT01162304 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-07-17

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Extended Release Oxycodone

40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours

DRUG

Immediate Release Oxycodone

IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Joel L Kent, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01162304 on ClinicalTrials.gov