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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Analgesics, Opioid; Oxymorphone

Criteria

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).