A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Primary Purpose
Chronic Nociceptive Pain, Neuropathic Pain, Non-cancer Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxymorphone ER
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Nociceptive Pain focused on measuring Oral morphine, oxycodone, OPANA, Oxymorphone, pain, nociceptive, neuropathic, rotation, titration, mixed origin non-cancer pain
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older.
- 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 three months and at least a total daily Opioid dose of 60mg 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 probably sleep apnea).
- History of illicit drug or alcohol dependence or abuse, abnormal drug taking/seeking behaviors.
- Sever depression (> 26 on the BDI) or severe anxiety or insomnia requiring chronic daily use of benzodiazepines or hypnotic drugs.
- 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).
- Hypersensitivity to study medication (Oxymorphone).
Sites / Locations
- Mount Sinai School of MedicineRecruiting
Outcomes
Primary Outcome Measures
The safety of rapid Opioid rotation
Secondary Outcome Measures
Full Information
NCT ID
NCT00945919
First Posted
July 22, 2009
Last Updated
July 23, 2009
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Endo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00945919
Brief Title
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Official Title
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.
Detailed Description
This project will enroll 12 volunteers who suffer from chronic pain. Potential participants must be on one of the following therapies:
Long acting morphine
Oxycodone Participants will be asked to complete a pain diary for approximately 10 days and to stop taking their current pain medications the night before they are admitted o the GCRC. Once the patients present at the GCRC, they will be started on the IV PCA (Patient Controlled Analgesia) Oxymorphone to control their pain. Titration will take approximately a total of 8 hrs. At the end of the titration period, patients will be discharged home on OPANA ER. The oral dose will be calculated based on the IV PCA use. During the titration, patients' pain, vital and side effects will be assessed hourly until the 8th hour of the IV PCA titration.
Patients will be contacted daily by a member of the study team to assess pain and side effects. The OPANA ER dose will be adjusted as needed to adequately manage both.
If patients do not feel as though they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.
Patients will undergo an exit examination 2 weeks after they were admitted to the GCRC in order to assess pain relief. In addition, a final follow-up telephone interview will take place 6 weeks after the initial 1-day stay at the GCRC. Our research staff or physicians will ask about your pain treatment and ask which Opioid medication you are currently taking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nociceptive Pain, Neuropathic Pain, Non-cancer Pain
Keywords
Oral morphine, oxycodone, OPANA, Oxymorphone, pain, nociceptive, neuropathic, rotation, titration, mixed origin non-cancer pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxymorphone ER
Intervention Description
Rapid Opioid rotation/titration
Primary Outcome Measure Information:
Title
The safety of rapid Opioid rotation
Time Frame
Daily for two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older.
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 three months and at least a total daily Opioid dose of 60mg 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 probably sleep apnea).
History of illicit drug or alcohol dependence or abuse, abnormal drug taking/seeking behaviors.
Sever depression (> 26 on the BDI) or severe anxiety or insomnia requiring chronic daily use of benzodiazepines or hypnotic drugs.
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).
Hypersensitivity to study medication (Oxymorphone).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Pappagallo, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Pappagallo
Phone
212-241-7631
Email
marco.pappagallo@mountsinai.org
12. IPD Sharing Statement
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A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
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