Status:
COMPLETED
Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Pain
Chronic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.
Detailed Description
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 titrat...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00911287
Start Date
June 1 2003
End Date
March 1 2004
Last Update
February 10 2010
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