Chronic PainPhase 3NCT00911261
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
A Phase 3 study testing Oxymorphone Extended Release in people with Chronic Pain and Neuropathic Pain, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Neuropathic Pain, Cancer
- What is being tested?
- Oxymorphone Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to May 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
- ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:
- have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or
- have intolerable side effects to one or more components of their current opioid-containing analgesic regimen.
- Currently receive a stable (at least 2 weeks duration) analgesic regimen
- If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
- Understand written and spoken English
Show all 19Show fewer
- Have been informed of the nature of the study and provided written informed consent
- Additional Inclusion Criteria for Cancer Patients Only:
- Have a life expectancy of at least 12 months
- Additional Inclusion Criteria for Neuropathic Patients Only:
- Have a diagnosis of:
- post-herpetic neuralgia (PHN)
- diabetic neuropathy (DN)
- complex regional pain syndrome (CRPS)
- HIV neuropathy
- idiopathic sensory neuropathy
- traumatic peripheral neuropathy
- central neuropathic pain condition (spinal cord injury, post-stroke pain), OR
- other peripheral neuropathy (upon mutual agreement of the sponsor and investigator).
Who cannot join
- Have a positive pregnancy test (females only)
- Have a history of or active asthma or emphysema
- Have clinically significant hepatic impairment
- Have a history of alcohol or substance abuse within the last 3 years
- Have a history of opioid abuse within 6 months prior to study entry
- Have a known allergy or significant reaction to opioids, including codeine
- Have a known oxymorphone sensitivity or allergy
- Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
About this study
Official title: An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.
Read the detailed description
The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.
- Conditions
- Chronic Pain, Neuropathic Pain, Cancer
- Being tested
- Oxymorphone Extended Release
- Keywords
- Cancer Pain, Neuropathic Pain, Extended Release, Long-Acting Opioid, Oxymorphone
- Medical subject headings
- Chronic Pain, Neuralgia, Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone Extended ReleaseDrug
- Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets
- Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets
- Treatment will consist of up to 12 months of dosing with Oxymorphone ER.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Oxymorphone Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Measured: Throughout the study
Secondary outcomes (8)
Average daily pain intensity (Question 5 of BPI)
Measured: Week 1-4, Month 12
Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
Measured: Week 1-4, Month 12
Average daily dose of oxymorphone ER
Measured: Daily
Average daily dose of rescue medication
Measured: Daily
Total daily dose of oxymorphone ER and rescue medication
Measured: Daily
Time to stabilization
Measured: Month 12
Patient/investigator global assessment of pain relief
Measured: Month 12
Treatment Satisfaction
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startAug 2003
- Primary completionMar 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911261
- Sponsor's protocol ID
- EN3202-029
- Status last verified
- Feb 2010
- First submitted
- 15 May 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00911261
- Acronym / sponsor ID
- EN3202-029
- Conditions
- Chronic Pain, Neuropathic Pain, Cancer
- Keywords
- Cancer Pain, Neuropathic Pain, Extended Release, Long-Acting Opioid, Oxymorphone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 1 Jun 2009 (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 determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.
Detailed description
The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Oxymorphone Extended Release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:
- Currently receive a stable (at least 2 weeks duration) analgesic regimen
- If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
- Understand written and spoken English
- Have been informed of the nature of the study and provided written informed consent
Key exclusion criteria (8 listed)
- Have a positive pregnancy test (females only)
- Have a history of or active asthma or emphysema
- Have clinically significant hepatic impairment
- Have a history of alcohol or substance abuse within the last 3 years
- Have a history of opioid abuse within 6 months prior to study entry
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* Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets * Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets * Treatment will consist of up to 12 months of dosing with Oxymorphone ER. | Drug | Single Arm |
Primary outcome
Tolerability
Time frame: Throughout the study
8 secondary outcomes
Average daily pain intensity (Question 5 of BPI)
Time frame: Week 1-4, Month 12
Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
Time frame: Week 1-4, Month 12
Average daily dose of oxymorphone ER
Time frame: Daily
Average daily dose of rescue medication
Time frame: Daily
Total daily dose of oxymorphone ER and rescue medication
Time frame: Daily
Time to stabilization
Time frame: Month 12
Patient/investigator global assessment of pain relief
Time frame: Month 12
Treatment Satisfaction
Time frame: Month 12
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 15 Feb 2010.
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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.
Study Director study director
Endo USA Inc., a Keenova Therapeutics Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxymorphone Extended Release in people with Chronic Pain and Neuropathic Pain, run by Endo USA Inc., a Keenova Therapeutics Company.
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 19 inclusion and 8 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 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Tolerability (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2010.