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
|