Chronic PainPhase 3NCT00765856
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
A Phase 3 study testing Oxymorphone ER in people with Chronic Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 13 sites in United States.
Trial summary
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Oxymorphone ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 13 sitesUnited States
- Study dates
- 17 Nov 2008to 22 Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have 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 greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
- Weigh at least 50 kg
- Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Who cannot join
- Have a life expectancy <4 weeks
- Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
- Have dysphagia or difficulty swallowing whole tablets
- Have a previous exposure to oxymorphone
- Have an ileostomy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
The Children's Hospital
Aurora, Colorado, 80045
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Hershey Medical Center
Hershey, Pennsylvania, 17112
Rehabilitation Associates of Indiana
Indianapolis, Indiana, 46250
Florida Institute of Medical Research
Jacksonville, Florida, 32257
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
Little Rock, Arkansas, 72202
University of Louisville Reserach Foundation, Inc.
Louisville, Kentucky, 40202
Taylor Research, LLC
Marietta, Georgia, 30060
Tukoi Clinical Research
Miami, Florida, 34104
Stanford University School of Medicine
Stanford, California, 94305
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33618
Children's National Medical Center
Washington D.C., District of Columbia, 20010
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
Read the detailed description
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
- Conditions
- Chronic Pain
- Being tested
- Oxymorphone ER
- Keywords
- Opioid tolerant, Pediatric, Male 6-17 years of age, Female 6-17 years of age, Pain, Non malignant, Malignant
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone ERDrug
Also called Opana ER, Opana
Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications
| Study group | Role | What they receive |
|---|---|---|
| Oxymorphone ER | Experimental | Not described Receives: Drug: Oxymorphone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Measured: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary outcomes (4)
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Measured: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Measured: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Measured: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Measured: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study start17 Nov 2008
- Primary completion22 Feb 2010
- Study completion22 Feb 2010
Why it stopped: Terminated new protocol developed which incorporated Pharmacokinetics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Director CR&D, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765856
- Sponsor's protocol ID
- EN3202 036
- Status last verified
- Nov 2020
- First submitted
- 2 Oct 2008
- Last updated
- 16 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
- ClinicalTrials.gov ID
- NCT00765856
- Acronym / sponsor ID
- EN3202 036
- Conditions
- Chronic Pain
- Keywords
- Opioid tolerant, Pediatric, Male 6-17 years of age, Female 6-17 years of age, Pain, Non malignant, Malignant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated new protocol developed which incorporated Pharmacokinetics
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 22 Feb 2010 (actual)
- Study completion
- 22 Feb 2010 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
Detailed description
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxymorphone ER | Experimental | Drug: Oxymorphone ER |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Have 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 greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
- Weigh at least 50 kg
- Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Key exclusion criteria (5 listed)
- Have a life expectancy <4 weeks
- Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
- Have dysphagia or difficulty swallowing whole tablets
- Have a previous exposure to oxymorphone
- Have an ileostomy
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 ERAlso: Opana ER, OpanaOxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications | Drug | Oxymorphone ER |
Primary outcome
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
4 secondary outcomes
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sr. Director CR&D study director
Endo USA Inc., a Keenova Therapeutics Company
13 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 ER in people with Chronic Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 13 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose (time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)). 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 16 Dec 2020.