A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Mount Sinai School of Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Mount Sinai School of Medicine
Collaborator:
Endo Pharmaceuticals
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00945919
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Nociceptive Pain Neuropathic Pain Non-cancer Pain |
Drug: Oxymorphone ER |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone |
Resource links provided by NLM:
Further study details as provided by Mount Sinai School of Medicine:
Primary Outcome Measures:
- The safety of rapid Opioid rotation [ Time Frame: Daily for two weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Oxymorphone ER
Rapid Opioid rotation/titration
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945919
Locations
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Marco Pappagallo 212-241-7631 marco.pappagallo@mountsinai.org | |
Sponsors and Collaborators
Mount Sinai School of Medicine
Endo Pharmaceuticals
Investigators
| Principal Investigator: | Marco Pappagallo, MD | Mount Sinai School of Medicine |
More Information
No publications provided
| Responsible Party: | Marco Pappagallo, MD, Director of Pain Research and Development, Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00945919 History of Changes |
| Other Study ID Numbers: | GCO# 08-1423 |
| Study First Received: | July 22, 2009 |
| Last Updated: | July 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mount Sinai School of Medicine:
|
Oral morphine oxycodone OPANA Oxymorphone pain |
nociceptive neuropathic rotation titration mixed origin non-cancer pain |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Oxymorphone Analgesics, Opioid Adjuvants, Anesthesia |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013