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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Oxymorphone

• Registration Number: NCT00580294
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-24
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2015-11-25
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Results First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
oxymorphone	Oxymorphone	participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed

Primary Outcome Measures

Name	Time	Method
Change in Patient Global Impression of Change	baseline and 12 hours	PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)
Brief Pain Inventory	Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment

Trial Locations

Locations (1)

Icahn School of Medcine at Mount Sinai; 🇺🇸 New York, New York, United States