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

NCT00945919 | Unknown

• 1 other identifier: GCO# 08-1423
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The safety of rapid Opioid rotation

  Daily for two weeks

Interventions

Oxymorphone ER DRUG

Rapid Opioid rotation/titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Neuralgia; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Pappagallo, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: July 24, 2009

Record last verified: 2009-07

Locations

US (1)