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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Oxymorphone

Intervention Type DRUG

IV PO

Interventions

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Oxymorphone

IV PO

Intervention Type DRUG

Other Intervention Names

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Oxymorphone PO Oxymorphone IV

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No