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

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: Oxymorphone Extended Release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Endo Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change in pain intensity from baseline (pre-randomization) to last assessment.

Secondary outcome:

- Time to early discontinuation due to lack of efficacy

- Patient's Global Assessment of Pain Medication

- Physician's Global Assessment of Pain Medication

- Pain Quality Assessment Scale

- Safety as measured by AEs

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Southern Drug Research, Hueytown, Alabama 35023, United States

Arizona Research, Phoenix, Arizona 85023, United States

Phoenix Center for Clinical Research, Phoenix, Arizona 85015, United States

Express Care Clinical Research, Colorado Springs, Colorado 80909, United States

Glasgow Family Practice, Newark, Delaware 19702, United States

Radiant Research, Daytona Beach, Florida 32114, United States

University Clinical Research, Deland, Florida 32720, United States

LCFP Inc., Fort Myers, Florida 33907, United States

Century Clinical Research, Holly Hill, Florida 32117, United States

Ocala Rheumatology Research Center, Ocala, Florida 34474, United States

The Arthritis Center, Palm Harbor, Florida 34684, United States

Radiant Research, Pinellas Park, Florida 33781, United States

Park Place Therapeutic Center, Plantation, Florida 33324, United States

Comprehensive Neurology Specialists, Atlanta, Georgia 30338, United States

Comprehensive Neuroscience, Atlanta, Georgia 30338, United States

Pain Specialists of Greater Chicago, Burr Ridge, Illinois 60527, United States

Mid-America Physiatrists, Overland Park, Kansas 66211, United States

Research Medical Center, Kansas City, Missouri 64132, United States

Radiant Research, St. Louis, Missouri 63141, United States

Comprehensive Clinical Research, Berlin, New Jersey 08009, United States

Piedmont Anesthesia, Winston-Salem, North Carolina 27103, United States

Health Research Institute, Oklahoma City, Oklahoma 73109, United States

Pain Consultants of Oregon, Eugene, Oregon 97401, United States

Keystone Medical Research, Altoona, Pennsylvania 16602, United States

Perkiomen Valley Family Practice, Collegeville, Pennsylvania 19426, United States

Feasterville Family Health Center, Feasterville, Pennsylvania 19053, United States

Fleetwood Clinical Research, Fleetwood, Pennsylvania 19522, United States

Paragon Clinical Research, Cranston, Rhode Island 02920, United States

Waccamaw Pain Management, Murrells Inlet, South Carolina 29576, United States

KRK Medical Research, Richardson, Texas 75080, United States

Jean Brown Research, Salt Lake City, Utah 84124, United States

Additional Information

Starting date: October 2004
Last updated: February 12, 2010

Page last updated: August 23, 2015

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