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

An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.

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

Study Overview

• Status: Completed
• Conditions: Pain; Chronic Disease
• Intervention / Treatment: Drug: Oxymorphone extended release

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 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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerability.	Entire study duration, including follow-up period.

Secondary Outcome Measures

Outcome Measure	Time Frame
Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period	Week 1-4, Month 1-6
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire	Week 1-4, Month 1-6
Average daily dose of oxymorphone ER	Entire study duration
Rescue medication.	Entire study duration
Total daily dose of oxymorphone ER and rescue medication	Entire study duration
Time to stabilization. Patient/investigator global assessments	Month 6
Treatment satisfaction	Month 6

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Publications and helpful links

General Publications

• Fitzgerald JE, Simpson JA, Acheson AG. The use of intravenous iron in patients with cancer related anaemia: don't overlook iron deficiency anaemia in colorectal cancer. Br J Haematol. 2008 Dec;143(5):754; author reply 755. doi: 10.1111/j.1365-2141.2008.07415.x. No abstract available.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Estimate): February 10, 2010
• Last Update Submitted That Met QC Criteria: February 9, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Chronic pain; Opioid; Extended Release; Oxymorphone; Long-Acting Opioid; Opioid-Naive
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Chronic Pain; Chronic Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxymorphone
• Other Study ID Numbers: EN3202-028