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

Sponsor:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00225797

Purpose

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.

Condition	Intervention	Phase
Chronic Pain	Drug: Oxymorphone Extended Release	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Oxymorphone Oxymorphone hydrochloride

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	160
Study Start Date:	November 2004
Estimated Study Completion Date:	July 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225797

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Locations

United States, Alabama
Southern Drug Research
Hueytown, Alabama, United States, 35023
United States, Arizona
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
United States, Colorado
Express Care Clinical Research
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
New England Research
Bridgeport, Connecticut, United States, 06606
United States, Delaware
Glasgow Family Practice
Newark, Delaware, United States, 19702
United States, Florida
Ocala Rheumatology Research Center
Ocala, Florida, United States, 34474
Radiant Research
Daytona Beach, Florida, United States, 32114
University Clinical Research
Pembroke Pines, Florida, United States, 33024
Park Place Therapeutic Center
Plantation, Florida, United States, 33324
The Arthritis Center
Palm Harbor, Florida, United States, 34684
Radiant Research
Pinellas Park, Florida, United States, 33781
ICSL Clinical Studies
St Petersburg, Florida, United States, 33702
LCFP Inc
Ft. Myers, Florida, United States, 33907
University Clinical Research
Deland, Florida, United States, 32720
Century Clinical Research
Holly Hill, Florida, United States, 32117
United States, Georgia
Comprehensive Neuroscience
Atlanta, Georgia, United States, 30338
Comprehensive Neurology Specialists
Atlanta, Georgia, United States, 30338
United States, Illinois
Pain Specialists of Greater Chicago
Burr Ridge, Illinois, United States, 60527
United States, Kansas
Mid-America Physiatrists
Overland Park, Kansas, United States, 66211
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
Radiant Research
St. Louis, Missouri, United States, 63141
United States, North Carolina
Piedmont Anesthesia
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Perkiomen Valley Family Practice
Collegeville, Pennsylvania, United States, 19426
Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States, 19522
Keystone Clinical Solutions
Altoona, Pennsylvania, United States, 16602
Feasterville Family Health Center
Feasterville, Pennsylvania, United States, 19053
United States, Rhode Island
New England Center for Clinical Research
Cranston, Rhode Island, United States, 02920
Paragon Clinical Research
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Radiant Research
Greer, South Carolina, United States, 29651
Waccamaw Pain Management
Murrells Inlet, South Carolina, United States, 29576
United States, Texas
KRK Medical Research
Richardson, Texas, United States, 75080
United States, Utah
Intermountain Clinical Research
Salt Lake City, Utah, United States, 84102
Jean Brown Research
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Endo Pharmaceuticals

More Information

No publications provided by Endo Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	( Sr. Director Clinical R&D )
Study ID Numbers:	EN3202-031
Study First Received:	September 22, 2005
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00225797 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

chronic pain
lower back
opioid
efficacy
safety

Additional relevant MeSH terms:

Adjuvants, Anesthesia
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid
Oxymorphone

ClinicalTrials.gov processed this record on November 30, 2009