Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-03-31

Brief Summary

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The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.

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Detailed Description

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The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.

Conditions

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Pain Chronic Disease

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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Single Arm

Group Type EXPERIMENTAL

Oxymorphone extended release

Intervention Type DRUG

Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.

Interventions

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Oxymorphone extended release

Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Currently receive a stable non-opioid analgesic regimen
* Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
* If female, must be practicing abstinence or using a medically acceptable form of contraception
* Understand written and spoken English
* Have been informed of the nature of the study and provided written informed consent.

Exclusion Criteria

* Positive pregnancy test (females only)
* History of or active asthma or emphysema
* Clinically significant hepatic impairment
* Received any of the following medications within 48 hours prior to dosing:

* Dextromethorphan-containing medications (over-the-counter \[OTC\] cough and cold preparations, such as Vicks Formula 44)
* St. John's Wort \>1000 mg/day
* Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
* Are not stabilized on the following medications for at least 4 weeks prior to dosing:

* Tricyclic antidepressant drugs
* Serotonin reuptake inhibitors
* Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
* History of alcohol or substance abuse within the last 3 years
* History of opioid abuse within 6 months prior to study entry
* Have a known oxymorphone sensitivity or allergy
* Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
* Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
* Have a known allergy or significant reaction to opioids
* Have been a participant in a previous oxymorphone clinical trial
* Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No