Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain

Chronic Pain Clinical Trial

Official title:

An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Experienced Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226421
• Other study ID #: EN3202-032
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: August 2005

Study information

• Verified date: December 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.

Description:

Patients with chronic low back pain on stable opioid treatment will be converted to oxymorphone extended release (ER)and enter an open-label treatment phase.During the Open-Label Titration Period (up to 28 days), patients will receive daily oxymorphone ER PO q12h. Patients stabilized on a dose that provides adequate pain relief will be randomized to either continue on the stabilized dose of oxymorphone ER or receive placebo in a double-blind fashion for a total duration of 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females 18 years of age or older

• In good health as determined by the Investigator on the basis of medical history and physical examination.

• Moderate to severe chronic non-neuropathic low back pain that has been present daily for at least several hours per day for a minimum of three months prior to the screening.

• On a stable around-the-clock opioid pain medication for the management of moderate to severe chronic lower back pain.

• Expected to require a total daily oxymorphone ER dose that is a minimum of 20 mg per day (oral morphine equivalent: approximately 60 mg) and will not exceed 220 mg oxymorphone ER (oral morphine requirement: approximately 660 mg).

• Any adjunct therapy for back pain such as physical therapy, biofeedback therapy, acupuncture therapy or herbal remedies, based on the patient's current status should remain unchanged during the period of participation of the patient.

• Written informed consent

Exclusion Criteria:

• Pregnant and/or lactating

• Subjects with radiculopathy, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, severe lower extremity weakness or numbness, bowel or bladder dysfunction secondary to cauda equina compression, diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection or tumor.

• Cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, Botulinum toxin injections, or inhalation analgesia). The patient must not have a nerve/plexus block within 4 weeks of screening (Visit 1). The patient must not have a Botulinum toxin injection in the lower back region within 3 months of screening.

• Intend to alter their physical therapy regimen during the study.

• Surgical procedures directed towards the source of back pain within 6 months of screening.

• Pain which is secondary to confirmed or suspected neoplasm.

• Dysphagia or difficulty swallowing tablets or capsules.

• Significant prior history of substance abuse or alcohol abuse.

• Use of any investigational medication within 30 days prior to the first dose of study medication.

• Previous exposure to oxymorphone.

• History of clinically significant intolerance to oxymorphone or a known hypersensitivity to opioid analgesics.

• History of seizure.

• use of MAO inhibitor within 14 days prior to the start of study medication.

• Other clinically significant conditions as judged by the investigator.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Oxymorphone Extended Release

Locations

Country	Name	City	State
United States	Keystone Medical Research	Altoona	Pennsylvania
United States	Comprehensive Neurology Specialists	Atlanta	Georgia
United States	Comprehensive Neuroscience	Atlanta	Georgia
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Pain Specialists of Greater Chicago	Burr Ridge	Illinois
United States	Perkiomen Valley Family Practice	Collegeville	Pennsylvania
United States	Express Care Clinical Research	Colorado Springs	Colorado
United States	Paragon Clinical Research	Cranston	Rhode Island
United States	Radiant Research	Daytona Beach	Florida
United States	University Clinical Research	DeLand	Florida
United States	Pain Consultants of Oregon	Eugene	Oregon
United States	Feasterville Family Health Center	Feasterville	Pennsylvania
United States	Fleetwood Clinical Research	Fleetwood	Pennsylvania
United States	LCFP Inc.	Fort Myers	Florida
United States	Century Clinical Research	Holly Hill	Florida
United States	Southern Drug Research	Hueytown	Alabama
United States	Research Medical Center	Kansas City	Missouri
United States	Waccamaw Pain Management	Murrells Inlet	South Carolina
United States	Glasgow Family Practice	Newark	Delaware
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Mid-America Physiatrists	Overland Park	Kansas
United States	The Arthritis Center	Palm Harbor	Florida
United States	Arizona Research	Phoenix	Arizona
United States	Phoenix Center for Clinical Research	Phoenix	Arizona
United States	Radiant Research	Pinellas Park	Florida
United States	Park Place Therapeutic Center	Plantation	Florida
United States	KRK Medical Research	Richardson	Texas
United States	Radiant Research	Saint Louis	Missouri
United States	Jean Brown Research	Salt Lake City	Utah
United States	Piedmont Anesthesia	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity from baseline (pre-randomization) to last assessment.
Secondary	- Time to early discontinuation due to lack of efficacy
Secondary	- Patient's Global Assessment of Pain Medication
Secondary	- Physician's Global Assessment of Pain Medication
Secondary	- Pain Quality Assessment Scale
Secondary	- Safety as measured by AEs