Clinical trial NCT01162304
Conditions: Chronic Pain
Keywords: Chronic Pain This clinical trial will compare immediate-release (IR) oxycodone and extended-release (ER) oxycodone in the management of chronic pain
Sponsor: University of Rochester
Start date: 2010-03-01; Completion date: 2013-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed description:
This study is a single-center, randomized, open-label, 13-week, 2-period crossover clinical trial. Subjects will complete each of the following (unless they withdraw from the trial): (1) a one-week baseline period during which the subject completes pain diaries and remains on stable dosages of their existing pain medications; (2) immediate-release (IR) oxycodone 5 mg 3-4 pills every four hours; (3) extended-release (ER) oxycodone 40 mg 1 pill every 12 hours and IR-oxycodone 5 mg 1-2 pills every six hours. Subjects will be randomized to one of two treatment sequences (ER-oxycodone first then IR-oxycodone or vice verse). It is expected that this trial will take approximately 2 years to complete.

Crossover periods. Each of the two treatment periods will be 6 weeks in duration, which will allow ample time to assess pain relief, adverse effects, treatment satisfaction, and impact of treatment on health-related quality of life. There will be no need for a titration period at the beginning of either period or for a washout period before the second period because oxycodone at the same dosages will be administered in both periods. At each visit, subjects will be given sufficient medication to sustain them until at least the following visit.

Arms: arm 1: Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.

IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Interventions: intervention 1: Extended Release Oxycodone intervention 2: Immediate Release Oxycodone
Intervention descriptions: intervention 1: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours intervention 2: 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

Protocol documents: