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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Show 33 Study Locations

Sponsors and Collaborators

Endo Pharmaceuticals

More Information

No publications provided by Endo Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
ClinicalTrials.gov Identifier:	NCT00225797 History of Changes
Other Study ID Numbers:	EN3202-031
Study First Received:	September 22, 2005
Last Updated:	February 12, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

chronic pain
lower back
opioid
efficacy
safety

Additional relevant MeSH terms:

Oxymorphone
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Opioid

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 12, 2012