Clinical trial NCT00225797: Efficacy and Safety of Oxmorphone Extended Release in 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-Naïve Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: chronic pain
lower back
opioid
efficacy
safety
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 160
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 non-cancer patients with chronic low back pain.

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.

Eligibility 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

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: 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: Colorado Springs
country: United States
facility: Express Care Clinical Research
state: Colorado
city: Bridgeport
country: United States
facility: New England Research
state: Connecticut
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: Pembroke Pines
country: United States
facility: University Clinical Research
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: Saint Petersburg
country: United States
facility: ICSL Clinical Studies
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: Winston-Salem
country: United States
facility: Piedmont Anesthesia
state: North Carolina
city: Altoona
country: United States
facility: Keystone Clinical Solutions
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: New England Center for Clinical Research
state: Rhode Island
city: Cranston
country: United States
facility: Paragon Clinical Research
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
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: Intermountain Clinical Research
state: Utah
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.
citation: Katz N, Rauck R, Ahdieh H, Ma T, Gerritsen van der Hoop R, Kerwin R, Podolsky G. A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain. Curr Med Res Opin. 2007 Jan;23(1):117-28. doi: 10.1185/030079906x162692.