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

Endo Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Chronic Disease

Pain

Treatments

Drug: Oxymorphone extended release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00911287

EN3202-028

Details and patient eligibility

About

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

Full 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 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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).