Chronic PainPhase 3NCT00225797
Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain
A Phase 3 study testing Oxymorphone Extended Release in people with Chronic Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Oxymorphone Extended Release
- How many people
- 160 participants
- Where
- 33 sitesUnited States
- Study dates
- Nov 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602
Comprehensive Neurology Specialists
Atlanta, Georgia, 30338
Comprehensive Neuroscience
Atlanta, Georgia, 30338
New England Research
Bridgeport, Connecticut, 06606
Pain Specialists of Greater Chicago
Burr Ridge, Illinois, 60527
Perkiomen Valley Family Practice
Collegeville, Pennsylvania, 19426
Express Care Clinical Research
Colorado Springs, Colorado, 80909
New England Center for Clinical Research
Cranston, Rhode Island, 02920
Paragon Clinical Research
Cranston, Rhode Island, 02920
Radiant Research
Daytona Beach, Florida, 32114
University Clinical Research
DeLand, Florida, 32720
Feasterville Family Health Center
Feasterville, Pennsylvania, 19053
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522
LCFP Inc
Fort Myers, Florida, 33907
Radiant Research
Greer, South Carolina, 29651
Century Clinical Research
Holly Hill, Florida, 32117
Southern Drug Research
Hueytown, Alabama, 35023
Research Medical Center
Kansas City, Missouri, 64132
Waccamaw Pain Management
Murrells Inlet, South Carolina, 29576
Glasgow Family Practice
Newark, Delaware, 19702
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Mid-America Physiatrists
Overland Park, Kansas, 66211
The Arthritis Center
Palm Harbor, Florida, 34684
University Clinical Research
Pembroke Pines, Florida, 33024
Phoenix Center for Clinical Research
Phoenix, Arizona, 85015
Radiant Research
Pinellas Park, Florida, 33781
Park Place Therapeutic Center
Plantation, Florida, 33324
KRK Medical Research
Richardson, Texas, 75080
Intermountain Clinical Research
Salt Lake City, Utah, 84102
Jean Brown Research
Salt Lake City, Utah, 84124
Radiant Research
St Louis, Missouri, 63141
ICSL Clinical Studies
St. Petersburg, Florida, 33702
Piedmont Anesthesia
Winston-Salem, North Carolina, 27103
About this 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
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.
Read the 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
- Being tested
- Oxymorphone Extended Release
- Keywords
- chronic pain, lower back, opioid, efficacy, safety
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone Extended ReleaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline (pre-randomization) to last assessment.
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225797
- Sponsor's protocol ID
- EN3202-031
- Status last verified
- Dec 2023
- First submitted
- 22 Sep 2005
- Last updated
- 2 Jan 2024
- Results posted
- No
Publications
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.
PubMed 22437221Peniston 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.
PubMed 20521870Katz 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.
PubMed 17257473
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00225797
- Acronym / sponsor ID
- EN3202-031
- Conditions
- Chronic Pain
- Keywords
- chronic pain, lower back, opioid, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Jul 2005
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymorphone Extended Release | Drug | – |
Primary outcome
Change in pain intensity from baseline (pre-randomization) to last assessment.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 22437221Peniston 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.
- Derived from this study: PubMed 20521870Peniston 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.
- Derived from this study: PubMed 17257473Katz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxymorphone Extended Release in people with Chronic Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline (pre-randomization) to last assessment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225797, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.