Open-Label Trial Comparing Oxycodone Medications (OUTCOMES)

This study has been terminated.
(unable to enroll subjects meeting Eligibility criteria)
Sponsor:
Information provided by (Responsible Party):
Joel Kent, University of Rochester
ClinicalTrials.gov Identifier:
NCT01162304
First received: April 27, 2010
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: Extended Release Oxycodone
Drug: Immediate Release Oxycodone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Numerical pain rating scale (NRS) [ Time Frame: Daily ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: Visits 2-6 ] [ Designated as safety issue: No ]
    Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.

  • Hospital Anxiety and Depression Scale [ Time Frame: Visits 2-6 ] [ Designated as safety issue: No ]
    The HADS will be administered to assess anxiety and depression.

  • Short Form Health Survey (SF-36) [ Time Frame: Visits 2, 4 and 6 ] [ Designated as safety issue: No ]
    It is a 36-item questionnaire designed to measure general health related quality of life.

  • Patient Global Impression of Change [ Time Frame: Visits 4 and 6 the end of each of the two treatment periods ] [ Designated as safety issue: No ]
    This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.


Estimated Enrollment: 40
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Extended release Oxycodone
Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Drug: Extended Release Oxycodone
40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
Other Name: Medication comparison
Active Comparator: 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 four 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
Other Name: Medication comparison

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 18 years old.
  2. Be able to read and understand English.
  3. Have a diagnosed chronic pain condition with pain every day or most days for the previous 6 months.
  4. 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.
  5. 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.
  6. Have completed at least 6 of the 7 daily diaries during the baseline week.
  7. 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.
  8. 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.
  9. Have the ability to either independently or with an accompanying person come to the research center for study visits.

Exclusion Criteria:

  1. Treatment of their chronic pain with nerve blocks or any other interventional procedure within the past 8 weeks.
  2. 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.
  3. History of suicide attempt within the past 2 years or current suicide plan or intent.
  4. History of excessive alcohol use or any illicit drug use within the past 2 years.
  5. 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).
  6. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162304

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Joel L Kent, MD University of Rochester
  More Information

No publications provided

Responsible Party: Joel Kent, Principal investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01162304     History of Changes
Other Study ID Numbers: 29813
Study First Received: April 27, 2010
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Chronic Pain
This clinical trial will compare immediate-release (IR)
oxycodone and extended-release (ER) oxycodone in the
management of chronic pain

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014