- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00580294
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
January 4, 2016 updated by: Icahn School of Medicine at Mount Sinai
A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone
The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients.
This study will examine if the switching from one pain medication to another can be done over a 24 hour period.
Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10029
- Icahn School of Medcine at Mount Sinai
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of 18 to no upper limit
- Chronic pain of nociceptive, neuropathic, or mixed origin
- Patients with chronic non cancer pain
- Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
- Pain of moderate intensity (>4, on the numerical scale 0-10) despite ongoing opioid therapy>
- Non-pregnant, non-lactating women
- Sufficient language skills to communicate with research staff
Exclusion Criteria:Non-ambulatory patients
- Clinically significant respiratory, renal, hepatic, or cardiac disease.
- Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
- History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
- Severe depression (> 26 on the BDI)
- Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).
- Workman compensation, current or pending medical-legal litigation
- Hypersensitivity to study medication (oxymorphone)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: oxymorphone
participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone.
After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
|
IV PO
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Global Impression of Change
Time Frame: baseline and 12 hours
|
PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)
|
baseline and 12 hours
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Brief Pain Inventory
Time Frame: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment
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Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marco Pappagallo, MD, Icahn School of Medcine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (ACTUAL)
August 1, 2008
Study Completion (ACTUAL)
August 1, 2008
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (ESTIMATE)
December 24, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
February 3, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
- Diabetes
- Arthritis
- Sciatica
- Osteoarthritis
- Chronic Pain
- Low Back Pain
- Scoliosis
- Migraine
- Headache
- Opioid
- Rheumatoid Arthritis
- Morphine
- Neck Pain
- Osteoporosis
- Fibromyalgia
- Back Pain
- Hip
- neuropathic
- Fracture
- oxycodone
- Neuropathic Pain
- Nerve pain
- Diabetic Neuropathies
- Foot Pain
- Complex Regional Pain Syndromes
- Oxymorphone
- Brachial Plexus Injury (stinger/burner)
- Contractures
- Herpes Zoster (shingles)
- Opana
- Opioid Rotation
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 07-0464
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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