Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain

Sponsor

Endo Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00226421

Collaborator

(none)

120

Enrollment

Locations

Duration (Months)

3.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: Oxymorphone Extended Release	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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-Experienced Patients With Chronic Low Back Pain

Study Start Date :

Oct 1, 2004

Study Completion Date :

Aug 1, 2005

Outcome Measures

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 []
- Pain Quality Assessment Scale []
- Safety as measured by AEs []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Drug Research	Hueytown	Alabama	United States	35023
2	Phoenix Center for Clinical Research	Phoenix	Arizona	United States	85015
3	Arizona Research	Phoenix	Arizona	United States	85023
4	Express Care Clinical Research	Colorado Springs	Colorado	United States	80909
5	Glasgow Family Practice	Newark	Delaware	United States	19702
6	Radiant Research	Daytona Beach	Florida	United States	32114
7	University Clinical Research	Deland	Florida	United States	32720
8	LCFP Inc.	Fort Myers	Florida	United States	33907
9	Century Clinical Research	Holly Hill	Florida	United States	32117
10	Ocala Rheumatology Research Center	Ocala	Florida	United States	34474
11	The Arthritis Center	Palm Harbor	Florida	United States	34684
12	Radiant Research	Pinellas Park	Florida	United States	33781
13	Park Place Therapeutic Center	Plantation	Florida	United States	33324
14	Comprehensive Neurology Specialists	Atlanta	Georgia	United States	30338
15	Comprehensive Neuroscience	Atlanta	Georgia	United States	30338
16	Pain Specialists of Greater Chicago	Burr Ridge	Illinois	United States	60527
17	Mid-America Physiatrists	Overland Park	Kansas	United States	66211
18	Research Medical Center	Kansas City	Missouri	United States	64132
19	Radiant Research	St. Louis	Missouri	United States	63141
20	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
21	Piedmont Anesthesia	Winston-Salem	North Carolina	United States	27103
22	Health Research Institute	Oklahoma City	Oklahoma	United States	73109
23	Pain Consultants of Oregon	Eugene	Oregon	United States	97401
24	Keystone Medical Research	Altoona	Pennsylvania	United States	16602
25	Perkiomen Valley Family Practice	Collegeville	Pennsylvania	United States	19426
26	Feasterville Family Health Center	Feasterville	Pennsylvania	United States	19053
27	Fleetwood Clinical Research	Fleetwood	Pennsylvania	United States	19522
28	Paragon Clinical Research	Cranston	Rhode Island	United States	02920
29	Waccamaw Pain Management	Murrells Inlet	South Carolina	United States	29576
30	KRK Medical Research	Richardson	Texas	United States	75080
31	Jean Brown Research	Salt Lake City	Utah	United States	84124