Clinical trial NCT00226421: Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant 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-Experienced Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: opioid
oxymorphone
chronic pain
randomized, double-blind trial
low back pain
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Change in pain intensity from baseline (pre-randomization) to last assessment.
Secondary outcomes:
measure: - Time to early discontinuation due to lack of efficacy
measure: - Patient's Global Assessment of Pain Medication
measure: - Physician's Global Assessment of Pain Medication
measure: - Pain Quality Assessment Scale
measure: - Safety as measured by AEs
Other outcomes:
Locations:
city: Hueytown
country: United States
facility: Southern Drug Research
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Center for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research
state: Arizona
city: Colorado Springs
country: United States
facility: Express Care Clinical Research
state: Colorado
city: Newark
country: United States
facility: Glasgow Family Practice
state: Delaware
city: Daytona Beach
country: United States
facility: Radiant Research
state: Florida
city: DeLand
country: United States
facility: University Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: LCFP Inc.
state: Florida
city: Holly Hill
country: United States
facility: Century Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Plantation
country: United States
facility: Park Place Therapeutic Center
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Neurology Specialists
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive Neuroscience
state: Georgia
city: Burr Ridge
country: United States
facility: Pain Specialists of Greater Chicago
state: Illinois
city: Overland Park
country: United States
facility: Mid-America Physiatrists
state: Kansas
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Winston-Salem
country: United States
facility: Piedmont Anesthesia
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Eugene
country: United States
facility: Pain Consultants of Oregon
state: Oregon
city: Altoona
country: United States
facility: Keystone Medical Research
state: Pennsylvania
city: Collegeville
country: United States
facility: Perkiomen Valley Family Practice
state: Pennsylvania
city: Feasterville
country: United States
facility: Feasterville Family Health Center
state: Pennsylvania
city: Fleetwood
country: United States
facility: Fleetwood Clinical Research
state: Pennsylvania
city: Cranston
country: United States
facility: Paragon Clinical Research
state: Rhode Island
city: Murrells Inlet
country: United States
facility: Waccamaw Pain Management
state: South Carolina
city: Richardson
country: United States
facility: KRK Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References:
citation: Peniston JH, Hu X, Potts SL, Wieman MS, Turk DC. Tolerability of concomitant use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors and oxymorphone extended release. Postgrad Med. 2012 Mar;124(2):114-22. doi: 10.3810/pgm.2012.03.2542.
citation: Peniston JH, Xiang Q, Gould EM. Factors affecting acceptability of titrated oxymorphone extended release in chronic low back pain - an individual patient analysis. Curr Med Res Opin. 2010 Aug;26(8):1861-71. doi: 10.1185/03007995.2010.490457.