Open-Label Trial Comparing Oxycodone Medications

NCT01162304 | Terminated Phase 4 Results DMC

• 1 other identifier: 29813
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NRS)

  The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p \< 0.05 level using a two-tailed test.

  Daily

Secondary Outcomes (4)

• Brief Pain Inventory

  Visits 2-6

• Hospital Anxiety and Depression Scale

  Visits 2-6

• Short Form Health Survey (SF-36)

  Visits 2, 4 and 6

• Patient Global Impression of Change

  Visits 4 and 6 the end of each of the two treatment periods

Study Arms (1)

ER Oxycodone vs IR Oxycodone

ACTIVE COMPARATOR

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

Drug: Extended Release Oxycodone; Drug: Immediate Release Oxycodone

Interventions

Extended Release Oxycodone DRUG

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

Also known as: Medication comparison

ER Oxycodone vs IR Oxycodone

Immediate Release Oxycodone DRUG

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

Also known as: Medication comparison

ER Oxycodone vs IR Oxycodone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years old.
• Be able to read and understand English.
• Have a diagnosed chronic pain condition with pain every day or most days for the previous 6 months.
• Be receiving the equivalent of no more than 40-120 mg daily of an opioid analgesic that can be safely converted to oxycodone; this dosage includes all use of opioid analgesics, including for "rescue" and for "breakthrough" pain.
• Have an average daily pain rating for the baseline week of pain ratings equal to 4.0 or greater on a 0-10 numerical pain rating scale (NRS) of average pain intensity in the past 24 hours.
• Have completed at least 6 of the 7 daily diaries during the baseline week.
• Have at least 5 baseline week pain diary ratings equal to 3 or greater on the 0-10 NRS, with no more than one rating of 9 and no ratings of 10.
• Have stable concomitant use of all pain-related medications for 8 weeks prior to screening and being willing to continue stable use of these medications for the duration of the trial.
• Have the ability to either independently or with an accompanying person come to the research center for study visits.

You may not qualify if:

• Treatment of their chronic pain with nerve blocks or any other interventional procedure within the past 8 weeks.
• A Beck Depression Inventory score \< 27 at baseline or clinically significant depression or dementia that, in the opinion of the investigator, may interfere with a subjects' adherence to the study protocol and/or the accurate and consistent reporting of pain.
• History of suicide attempt within the past 2 years or current suicide plan or intent.
• History of excessive alcohol use or any illicit drug use within the past 2 years.
• Lack of adequate birth control in pre-menopausal women of child-bearing age and/or a positive urine pregnancy test, which will be performed on all women except those \> 2 years post-menopausal or who have had a hysterectomy).
• History of malignancy within the past five years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joel Kent, MD
• Organization: University of Rochester

joel_kent@urmc.rochester.edu

585-273-2972

Study Officials

• Joel L Kent, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: July 14, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 17, 2015
• Results First Posted: July 17, 2015

Record last verified: 2014-01

Locations

US (1)