Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-Malignant Pain

Condition(s) targeted: Chronic Pain

Intervention: Oxymorphone Extended Release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Endo Pharmaceuticals

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

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-Naïve Patients With Chronic Low Back Pain

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Safety as measured by AEs

Detailed description: Patients with low back pain who are sub-optimally responsive to their current analgesic treatment begin open-label treatment with oxymorphone extended release (ER). During the Open-Label Titration Period, patients will receive daily oxymorphone ER by mouth (PO) q12h. The investigator will initiate the Open-Label Titration Period using study drug at a dose of 5 mg PO q12h for 2 days; thereafter, patients will continue receiving 5 mg q12h or be titrated at increments of 5-10 mg q12h every 3-7 days until stabilization is achieved. The goal of the Open-Label Titration Period is to determine for each patient a fixed dose of study medication that is tolerated and achieves adequate analgesia. Stabilized patients will be randomiozed to either continue with current dose of oxymorphone ER or receive placebo for a total duration of 12 weeks.

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

Criteria:

Inclusion Criteria:

- Males or females 18 years of age or older

- opioid naïve

- Have an initial pain intensity score of at least 50 mm VAS

- In good health as determined by the investigator on the basis of medical history and

physical examination

- Have moderate to severe chronic non-neuropathic LBP that has been present daily for at

least several hours per day for a minimum of three months prior to the Screening

- 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

- 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, or inhalation analgesia). The patient must not have a nerve/plexus block within 4 weeks of screening

- Intend to alter 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, or an inability to take oral

medication

- 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

- Ileostomy or colostomy

- Use of MAO inhibitor within 14 days prior to the start of study medication

- Other clinically significant conditions as judged by the investigator

Southern Drug Research, Hueytown, Alabama 35023, United States

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

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

New England Research, Bridgeport, Connecticut 06606, United States

Glasgow Family Practice, Newark, Delaware 19702, United States

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

Radiant Research, Daytona Beach, Florida 32114, United States

University Clinical Research, Pembroke Pines, Florida 33024, United States

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

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

Radiant Research, Pinellas Park, Florida 33781, United States

ICSL Clinical Studies, St. Petersburg, Florida 33702, United States

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

University Clinical Research, Deland, Florida 32720, United States

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

Comprehensive Neuroscience, Atlanta, Georgia 30338, United States

Comprehensive Neurology Specialists, 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

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

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

Fleetwood Clinical Research, Fleetwood, Pennsylvania 19522, United States

Keystone Clinical Solutions, Altoona, Pennsylvania 16602, United States

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

New England Center for Clinical Research, Cranston, Rhode Island 02920, United States

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

Radiant Research, Greer, South Carolina 29651, United States

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

KRK Medical Research, Richardson, Texas 75080, United States

Intermountain Clinical Research, Salt Lake City, Utah 84102, United States

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

Starting date: November 2004
Ending date: July 2005
Last updated: September 22, 2005