Chronic PainPhase 3NCT01206907
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
A Phase 3 study testing oxymorphone IR in people with Chronic Pain, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- oxymorphone IR
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2013
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females 2 to ≤6 years of age, inclusive
- Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose >1 mg/kg qd oral morphine equivalent)
- Expected to continue to require a strong opioid for pain relief for at least 4 months
- Able to swallow the oxymorphone HCl immediate-release oral liquid
- Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements
Who cannot join
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy <4 months
- Any clinical condition in the investigator's opinion that would preclude participation
- Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
- Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
- Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
Show all 11Show fewer
- An ileostomy
- Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
- Investigator anticipates that the subject would be unable to comply with the protocol
- Parent/legal guardian is unable to complete the subject's daily study medication diary
- Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
About this study
Official title: AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
- Conditions
- Chronic Pain
- Being tested
- oxymorphone IR
- Keywords
- sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology
- Medical subject headings
- Chronic Pain, Anemia, Sickle Cell, Arthritis, Juvenile, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxymorphone IRDrug
oxymorphone IR liquid
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Measured: weekly for 1 month during titration
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Measured: bi-weekly for three months in the maintenance phase
Secondary outcomes (2)
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Measured: weekly for 1 month during titration
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Measured: bi-weekly for 3 months in the maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: The study is no longer required for the PREA for this product.
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
- 0 participants (actual)
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
- NCT01206907
- Sponsor's protocol ID
- EN3319-301
- Status last verified
- Aug 2012
- First submitted
- 17 Sep 2010
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID
- ClinicalTrials.gov ID
- NCT01206907
- Acronym / sponsor ID
- EN3319-301
- Conditions
- Chronic Pain
- Keywords
- sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is no longer required for the PREA for this product.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Sep 2010 (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 effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females 2 to ≤6 years of age, inclusive
- Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose >1 mg/kg qd oral morphine equivalent)
- Expected to continue to require a strong opioid for pain relief for at least 4 months
- Able to swallow the oxymorphone HCl immediate-release oral liquid
- Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements
Key exclusion criteria (11 listed)
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy <4 months
- Any clinical condition in the investigator's opinion that would preclude participation
- Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
- Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
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 IRoxymorphone IR liquid | Drug | – |
Primary outcome
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Time frame: weekly for 1 month during titration
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Time frame: bi-weekly for three months in the maintenance phase
2 secondary outcomes
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Time frame: weekly for 1 month during titration
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Time frame: bi-weekly for 3 months in the maintenance phase
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxymorphone IR in people with Chronic 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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 17 Aug 2012. 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 was withdrawn before enrolling participants, so there are no results.
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 to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. (time frame: weekly for 1 month during titration). The study lists 2 primary outcomes in all. 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 17 Aug 2012.