A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945919
Recruitment Status : Unknown
Verified July 2009 by Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
Endo Pharmaceuticals
Information provided by:
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Chronic Nociceptive Pain Neuropathic Pain Non-cancer Pain Drug: Oxymorphone ER Not Applicable

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they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Study Start Date : July 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Oxymorphone ER
    Rapid Opioid rotation/titration

Primary Outcome Measures :
  1. The safety of rapid Opioid rotation [ Time Frame: Daily for two weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945919

United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Marco Pappagallo    212-241-7631   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Endo Pharmaceuticals
Principal Investigator: Marco Pappagallo, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Marco Pappagallo, MD, Director of Pain Research and Development, Mount Sinai School of Medicine Identifier: NCT00945919     History of Changes
Other Study ID Numbers: GCO# 08-1423
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Icahn School of Medicine at Mount Sinai:
Oral morphine
mixed origin non-cancer pain

Additional relevant MeSH terms:
Nociceptive Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia