Expired Study
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New York, New York 10029


Purpose:

The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain.


Criteria:

Inclusion Criteria: - Age of 18 to no upper limit - 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 3 months of at least a total daily opioid dose of 60 mg 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 probable sleep apnea) - History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors - Severe depression (> 26 on the BDI) - 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). - Workman compensation, current or pending medical-legal litigation - Hypersensitivity to study medication (oxymorphone)


Study is Available At:


Original ID:

GCO# 07-0464


NCT ID:

NCT00580294


Secondary ID:


Study Acronym:


Brief Title:

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)


Official Title:

A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mount Sinai School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marco Pappagallo, MD
Principal Investigator
Mount Sinai School of Medcine

Study Dates

Start Date:November 2007
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:March 7, 2012
First Received Date:December 19, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Brief Pain Inventory
Time Frame:Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA tr
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Patient Global Impression of Change
Time Frame:end of study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:oxymorphone IV
Description:IV PO
Arm Name:1
Other Name:Oxymorphone PO

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Drug

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mount Sinai School of Medicine
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Endo Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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