Clinical trial NCT00911287: Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
Official title: An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Chronic Disease
Keywords: Chronic pain
Extended Release
Long-Acting Opioid
Opioid
Opioid-Naive
Oxymorphone
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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).

Primary outcomes:
measure: Tolerability.
timeFrame: Entire study duration, including follow-up period.
Secondary outcomes:
measure: Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period
timeFrame: Week 1-4, Month 1-6
measure: Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire
timeFrame: Week 1-4, Month 1-6
measure: Average daily dose of oxymorphone ER
timeFrame: Entire study duration
measure: Rescue medication.
timeFrame: Entire study duration
measure: Total daily dose of oxymorphone ER and rescue medication
timeFrame: Entire study duration
measure: Time to stabilization. Patient/investigator global assessments
timeFrame: Month 6
measure: Treatment satisfaction
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.