A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Unknown statusNot applicableNCT00945919
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
- Conditions
- Chronic Nociceptive Pain
- Neuropathic Pain
- Non-cancer Pain
- Interventions
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Start date
- 2009-07
- Primary completion
- 2010-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00945919