PainPhase 3NCT00911287
Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
A Phase 3 study testing Oxymorphone extended release in people with Pain and Chronic Disease, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Disease
- 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
- 129 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Mar 2004
- 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
- Currently receive a stable non-opioid analgesic regimen
- Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
- If female, must be practicing abstinence or using a medically acceptable form of contraception
- Understand written and spoken English
- Have been informed of the nature of the study and provided written informed consent.
Who cannot join
- Positive pregnancy test (females only)
- History of or active asthma or emphysema
- Clinically significant hepatic impairment
- Received any of the following medications within 48 hours prior to dosing:
- Dextromethorphan-containing medications (over-the-counter [OTC] cough and cold preparations, such as Vicks Formula 44)
- St. John's Wort >1000 mg/day
Show all 19Show fewer
- Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
- Are not stabilized on the following medications for at least 4 weeks prior to dosing:
- Tricyclic antidepressant drugs
- Serotonin reuptake inhibitors
- Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
- History of alcohol or substance abuse within the last 3 years
- History of opioid abuse within 6 months prior to study entry
- Have a known oxymorphone sensitivity or allergy
- Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
- 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
- Have a known allergy or significant reaction to opioids
- Have been a participant in a previous oxymorphone clinical trial
- Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).
About this study
Official title: An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.
The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.
Read the detailed description
The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.
- Conditions
- Pain, Chronic Disease
- Being tested
- Oxymorphone extended release
- Keywords
- Chronic pain, Extended Release, Long-Acting Opioid, Opioid, Opioid-Naive, Oxymorphone
- Medical subject headings
- Pain, Chronic Disease, Chronic 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, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 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: Entire study duration, including follow-up period.
Secondary outcomes (7)
Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period
Measured: Week 1-4, Month 1-6
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire
Measured: Week 1-4, Month 1-6
Average daily dose of oxymorphone ER
Measured: Entire study duration
Rescue medication.
Measured: Entire study duration
Total daily dose of oxymorphone ER and rescue medication
Measured: Entire study duration
Time to stabilization. Patient/investigator global assessments
Measured: Month 6
Treatment satisfaction
Measured: Month 6
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 startJun 2003
- Primary completionJan 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 129 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
- NCT00911287
- Sponsor's protocol ID
- EN3202-028
- Status last verified
- Feb 2010
- First submitted
- 15 May 2009
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Fitzgerald JE, Simpson JA, Acheson AG. The use of intravenous iron in patients with cancer related anaemia: don't overlook iron deficiency anaemia in colorectal cancer. Br J Haematol. 2008 Dec;143(5):754; author reply 755. doi: 10.1111/j.1365-2141.2008.07415.x. No abstract available.
PubMed 18950463
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.
- ClinicalTrials.gov ID
- NCT00911287
- Acronym / sponsor ID
- EN3202-028
- Conditions
- Pain, Chronic Disease
- Keywords
- Chronic pain, Extended Release, Long-Acting Opioid, Opioid, Opioid-Naive, Oxymorphone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Mar 2004 (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 ER is effective and safe in treating chronic pain in opioid-naive patients.
Detailed description
The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.
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 (5 listed)
- Currently receive a stable non-opioid analgesic regimen
- Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
- If female, must be practicing abstinence or using a medically acceptable form of contraception
- Understand written and spoken English
- Have been informed of the nature of the study and provided written informed consent.
Key exclusion criteria (19 listed)
- Positive pregnancy test (females only)
- History of or active asthma or emphysema
- Clinically significant hepatic impairment
- Received any of the following medications within 48 hours prior to dosing:
- Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
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 releaseStudy Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER. | Drug | Single Arm |
Primary outcome
Tolerability.
Time frame: Entire study duration, including follow-up period.
7 secondary outcomes
Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period
Time frame: Week 1-4, Month 1-6
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire
Time frame: Week 1-4, Month 1-6
Average daily dose of oxymorphone ER
Time frame: Entire study duration
Rescue medication.
Time frame: Entire study duration
Total daily dose of oxymorphone ER and rescue medication
Time frame: Entire study duration
Time to stabilization. Patient/investigator global assessments
Time frame: Month 6
Treatment satisfaction
Time frame: Month 6
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 10 Feb 2010.
- Background: PubMed 18950463Fitzgerald JE, Simpson JA, Acheson AG. The use of intravenous iron in patients with cancer related anaemia: don't overlook iron deficiency anaemia in colorectal cancer. Br J Haematol. 2008 Dec;143(5):754; author reply 755. doi: 10.1111/j.1365-2141.2008.07415.x. No abstract available.
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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 Pain and Chronic Disease, 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 5 inclusion and 19 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 10 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: Entire study duration, including follow-up period.). 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 NCT00911287, which also lists 1 linked publication.
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 10 Feb 2010.