Postoperative PainPhase 3NCT00801398
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
A Phase 3 study testing Oxymorphone IR in people with Postoperative Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 11 sites in United States.
Trial summary
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Oxymorphone IR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Feb 2009to 18 Apr 2011
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female > 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
Who cannot join
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of < 4 weeks
- Positive pregnancy test at screening
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The Children's Hospital
Aurora, Colorado, 80045
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Washington
Seattle, Washington, 98104
Stanford University School of Medicine
Stanford, California, 94305
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33607
Children's Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
- Conditions
- Postoperative Pain
- Being tested
- Oxymorphone IR
- Keywords
- Opioid tolerant, Pediatric, Pain, Non malignant, Malignant
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone IRDrug
Also called Opana IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
| Study group | Role | What they receive |
|---|---|---|
| Oxymorphone IR | Experimental | Open-Label, 2 part ascending-dose multicenter study Receives: Drug: Oxymorphone IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet
Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
Measured: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination
Subjects Taking Rescue Medication
Percentages are based on the number of subjects in each treatment group.
Measured: first dose through 48 hours after first dose
Secondary outcomes (6)
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule
Measured: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration
Measured: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Cmax of Single Dose of Oxymorphone by Treatment Group
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Measured: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Tmax of Single Dose of Oxymorphone by Treatment Group
Tmax: The time at which Cmax was observed
Measured: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group
λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)
Measured: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Half-life of Single Dose of Oxymorphone by Treatment Group
t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)
Measured: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study start17 Feb 2009
- Primary completion18 Apr 2011
- Study completion18 Apr 2011
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 Postoperative 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801398
- Sponsor's protocol ID
- EN3203-010
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2008
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00801398
- Acronym / sponsor ID
- EN3203-010
- Conditions
- Postoperative Pain
- Keywords
- Opioid tolerant, Pediatric, Pain, Non malignant, Malignant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2009 (actual)
- Primary completion
- 18 Apr 2011 (actual)
- Study completion
- 18 Apr 2011 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Posted 27 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxymorphone IR | Experimental | Drug: Oxymorphone IROpen-Label, 2 part ascending-dose multicenter study |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female > 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
Key exclusion criteria (3 listed)
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of < 4 weeks
- Positive pregnancy test at 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 IRAlso: Opana IROpen-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs | Drug | Oxymorphone IR |
Primary outcome
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet
Time frame: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination
Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
Subjects Taking Rescue Medication
Time frame: first dose through 48 hours after first dose
Percentages are based on the number of subjects in each treatment group.
6 secondary outcomes
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Cmax of Single Dose of Oxymorphone by Treatment Group
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Tmax of Single Dose of Oxymorphone by Treatment Group
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Half-life of Single Dose of Oxymorphone by Treatment Group
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- 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.
Study Director study director
Endo USA Inc., a Keenova Therapeutics Company
11 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 IR in people with Postoperative Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 11 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 4 inclusion and 3 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 27 Feb 2019). 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?
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet (time frame: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination). 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 27 Feb 2019.