Chronic Nociceptive PainNCT00945919
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
A study testing Oxymorphone ER in people with Chronic Nociceptive Pain and Neuropathic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Nociceptive Pain, Neuropathic Pain, Non-cancer Pain
- What is being tested?
- Oxymorphone ER
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2011
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai School of Medicine
New York, New York, 10029
Marco Pappagallo, 212-241-7631, marco.pappagallo@mountsinai.org
About this study
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.
Read the 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.
- Conditions
- Chronic Nociceptive Pain, Neuropathic Pain, Non-cancer Pain
- Being tested
- Oxymorphone ER
- Keywords
- Oral morphine, oxycodone, OPANA, Oxymorphone, pain, nociceptive, neuropathic, rotation, titration, mixed origin non-cancer pain
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone ERDrug
Rapid Opioid rotation/titration
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of rapid Opioid rotation
Measured: Daily for two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nociceptive PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Investigators
- Marco Pappagallo, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945919
- Sponsor's protocol ID
- GCO# 08-1423
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No