Recruiting

Ultra Rapid Opioid Rotation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT00945919

Conditions

Chronic Nociceptive Pain

Neuropathic Pain

Non-cancer Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxymorphone ER

Study Details

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.

Conditions

Chronic Nociceptive Pain

Neuropathic Pain

Non-cancer Pain

Study ID

NCT00945919

Start date

Jul, 2009

Status verified date

Jul, 2009

Completion date

May, 2011

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

Oxymorphone ER

Rapid Opioid rotation/titration

Primary outcome measure

  • The safety of rapid Opioid rotation [ Time Frame: Daily for two weeks ]

Central Contacts and Locations

Locations

Mount Sinai School of Medicine

Recruiting

New York, New York, United States, 10029

Contacts

Marco Pappagallo

212-241-7631marco.pappagallo@mountsinai.org

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 24, 2009

Last verified

Jul, 2009

Keywords

  • Oral morphine
  • oxycodone
  • OPANA
  • Oxymorphone
  • pain
  • nociceptive
  • neuropathic
  • rotation
  • titration
  • mixed origin non-cancer pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2009-07-24.