A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone - Full Text View

Sponsor:	Mount Sinai School of Medicine
Collaborator:	Endo Pharmaceuticals
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00945919

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:

Drug Information available for: Oxymorphone Oxymorphone hydrochloride

U.S. FDA Resources

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:

Rapid Opioid rotation/titration

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.

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 February 09, 2012