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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2004

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Single Arm

Clinical Trial Outcome Measures

Primary Measures

  • Tolerability.
    • Time Frame: Entire study duration, including follow-up period.

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Endo Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sr. Director, CR&D, Endo Pharmaceuticals Inc.
  • Overall Official(s)
    • Study Director, Study Director, Endo Pharmaceuticals

References

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.

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