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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911287
• Other study ID #: EN3202-028
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2009
• Last updated: February 9, 2010
• Start date: June 2003
• Est. completion date: March 2004

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability.		Entire study duration, including follow-up period.	Yes
Secondary	Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period		Week 1-4, Month 1-6	No
Secondary	Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire		Week 1-4, Month 1-6	No
Secondary	Average daily dose of oxymorphone ER		Entire study duration	No
Secondary	Rescue medication.		Entire study duration	No
Secondary	Total daily dose of oxymorphone ER and rescue medication		Entire study duration	No
Secondary	Time to stabilization. Patient/investigator global assessments		Month 6	No
Secondary	Treatment satisfaction		Month 6	No