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

NCT ID: NCT00225797

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2005-07-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Oxymorphone Extended Release

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Southern Drug Research

Hueytown, Alabama, United States

Phoenix Center for Clinical Research

Phoenix, Arizona, United States

Express Care Clinical Research

Colorado Springs, Colorado, United States

New England Research

Bridgeport, Connecticut, United States

Glasgow Family Practice

Newark, Delaware, United States

Radiant Research

Daytona Beach, Florida, United States

University Clinical Research

DeLand, Florida, United States

LCFP Inc

Fort Myers, Florida, United States

Century Clinical Research

Holly Hill, Florida, United States

Ocala Rheumatology Research Center

Ocala, Florida, United States

The Arthritis Center

Palm Harbor, Florida, United States

University Clinical Research

Pembroke Pines, Florida, United States

Radiant Research

Pinellas Park, Florida, United States

Park Place Therapeutic Center

Plantation, Florida, United States

ICSL Clinical Studies

St. Petersburg, Florida, United States

Comprehensive Neurology Specialists

Atlanta, Georgia, United States

Comprehensive Neuroscience

Atlanta, Georgia, United States

Pain Specialists of Greater Chicago

Burr Ridge, Illinois, United States

Mid-America Physiatrists

Overland Park, Kansas, United States

Research Medical Center

Kansas City, Missouri, United States

Radiant Research

St Louis, Missouri, United States

Piedmont Anesthesia

Winston-Salem, North Carolina, United States

Keystone Clinical Solutions

Altoona, Pennsylvania, United States

Perkiomen Valley Family Practice

Collegeville, Pennsylvania, United States

Feasterville Family Health Center

Feasterville, Pennsylvania, United States

Fleetwood Clinical Research

Fleetwood, Pennsylvania, United States

New England Center for Clinical Research

Cranston, Rhode Island, United States

Paragon Clinical Research

Cranston, Rhode Island, United States

Radiant Research

Greer, South Carolina, United States

Waccamaw Pain Management

Murrells Inlet, South Carolina, United States

KRK Medical Research

Richardson, Texas, United States

Intermountain Clinical Research

Salt Lake City, Utah, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22437221 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20521870 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17257473 (View on PubMed)

Other Identifiers

EN3202-031

Identifier Type: -

Identifier Source: org_study_id