Chronic PainPhase 3NCT04681027
Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children
A Phase 3 study testing Oxymorphone hydrochloride (HCl) in people with Chronic Pain and Postsurgical Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 5 sites in United States.
Trial summary
The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Chronic Pain, Postsurgical Pain
- What is being tested?
- Oxymorphone hydrochloride (HCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Mar 2013to Jan 2021
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Were males or females 7 - ≤17 years of age. Females of childbearing potential had to be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all menstruating females were considered to be of childbearing potential unless they were biologically sterile or surgically sterile for more than 1 year.
- Had chronic pain (malignant and/or nonmalignant) or postsurgical pain expected to require ATC opioid analgesia for up to 12 weeks with at least 10 mg per day oxymorphone ER (approximately equal to 30 mg per day oral MSE).
- Had a body weight at least 18 kg.
- Were able to swallow oxymorphone ER tablets.
- Had laboratory results from within 21 days prior to Baseline available including clinical chemistry and hematology laboratory analytes. Intraoperative (prior to surgical incision) labs were acceptable provided the results had been reviewed by the investigator for study eligibility prior to dosing.
- Subjects with postsurgical pain were prescribed a parenteral analgesic regimen utilizing a short-acting opioid analgesic AND were anticipated to be switched to an oral opioid for an extended period of time (according to institutions standard of care).
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- Were able to provide pain assessment evaluations using age-appropriate instruments provided in the protocol.
- Had been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s)/legal guardian(s) and subject, respectively, in accordance with IRB requirements.
- To participate in the PK Period, subjects had:
- Been hospital inpatients, expected to be hospitalized for up to 72 hours following the initial administration of oxymorphone ER.
- An indwelling access catheter in place for blood sampling.
Who cannot join
- Had known allergies or sensitivities to oxymorphone or other opioid analgesics.
- Had a known sensitivity to any component of the oxymorphone ER.
- Had a life expectancy <3 months.
- Was pregnant and/or lactating.
- Had cyanotic heart disease.
- Had respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study.
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- Had abdominal trauma that would interfere with absorption of oxymorphone ER.
- Had increased intracranial pressure.
- Had a respiratory condition requiring intubation.
- Had a history of uncontrolled seizures that were not managed with anticonvulsants.
- Had prior history of substance abuse or alcohol abuse.
- Had taken a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of oxymorphone ER.
- Had taken oxycodone or oxymorphone within 48 hours prior to Baseline.
- The investigator anticipated that the subject and/or parent(s)/legal guardian(s) was unable to comply with the protocol.
- The subject (and/or parent[s]/legal guardian[s]) was (were) unable to communicate effectively with study personnel.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Endo Clinical Trial Site #2
Nashville, Tennessee, 37232
Endo Clinical Trial Site #5
New Orleans, Louisiana, 70112
Endo Clinical Trial Site #1
Oklahoma City, Oklahoma, 73104
Endo Clinical Trial Site #3
Orange, California, 92868
Endo Clinical Trial Site #4
Pittsburgh, Pennsylvania, 15224
About this study
Official title: A Multicenter Study of the Safety, Tolerability, Effectiveness, and Pharmacokinetics of Oxymorphone HCL Extended-Release Tablets in Pediatric Subjects Requiring an Around-The-Clock Opioid for an Extended Period of Time
The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period.
- Conditions
- Chronic Pain, Postsurgical Pain
- Being tested
- Oxymorphone hydrochloride (HCl)
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone hydrochloride (HCl)Drug
Also called OPANA® ER (oxymorphone HCl) Extended-Release Tablets
Opioid
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Age Groups: 7 to ≤12 years | Active comparator | Participants expected to require ATC opioids for an extended period of time Receives: Drug: Oxymorphone hydrochloride (HCl) |
| Pediatric Age Groups: 13 to ≤17 years | Active comparator | Participants expected to require ATC opioids for an extended period of time Receives: Drug: Oxymorphone hydrochloride (HCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Score using FPS-R
Faces Pain Scale - Revised (FPS-R) self-report measure used to assess pain intensity in participants ages 7 - ≤12 years old, consists of 6 faces, visually representing increasing changes in pain intensity bounded on the left by "no pain" and on the right by "very much pain".
Measured: 14 Days Post Last Dose
Pain Intensity Score using NRS-11
Numerical Rating Scale (NRS-11) is an 11-point categorical numerical rating scale to assess pain intensity in participants ages 13 - ≤17 years old. The scale is anchored on the left with "No Pain" and is anchored on the right with "Worst Possible Pain".
Measured: 14 Days Post Last Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start11 Mar 2013
- Primary completion4 Apr 2017
- Study completionJan 2021 (estimated)
Why it stopped: Study Suspended 06Feb2020 per FDA Request
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saji Vijayan, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681027
- Sponsor's protocol ID
- EN3202-037
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Safety, Tolerability, Effectiveness, and Pharmacokinetics of Oxymorphone HCL Extended-Release Tablets in Pediatric Subjects Requiring an Around-The-Clock Opioid for an Extended Period of Time
- ClinicalTrials.gov ID
- NCT04681027
- Acronym / sponsor ID
- EN3202-037
- Conditions
- Chronic Pain, Postsurgical Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study Suspended 06Feb2020 per FDA Request
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 23 Dec 2020 (actual)
- 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 was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Age Groups: 7 to ≤12 years | Active comparator | Drug: Oxymorphone hydrochloride (HCl)Participants expected to require ATC opioids for an extended period of time |
| Pediatric Age Groups: 13 to ≤17 years | Active comparator | Drug: Oxymorphone hydrochloride (HCl)Participants expected to require ATC opioids for an extended period of time |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Were males or females 7 - ≤17 years of age. Females of childbearing potential had to be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all menstruating females were considered to be of childbearing potential unless they were biologically sterile or surgically sterile for more than 1 year.
- Had chronic pain (malignant and/or nonmalignant) or postsurgical pain expected to require ATC opioid analgesia for up to 12 weeks with at least 10 mg per day oxymorphone ER (approximately equal to 30 mg per day oral MSE).
- Had a body weight at least 18 kg.
- Were able to swallow oxymorphone ER tablets.
- Had laboratory results from within 21 days prior to Baseline available including clinical chemistry and hematology laboratory analytes. Intraoperative (prior to surgical incision) labs were acceptable provided the results had been reviewed by the investigator for study eligibility prior to dosing.
Key exclusion criteria (15 listed)
- Had known allergies or sensitivities to oxymorphone or other opioid analgesics.
- Had a known sensitivity to any component of the oxymorphone ER.
- Had a life expectancy <3 months.
- Was pregnant and/or lactating.
- Had cyanotic heart disease.
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 hydrochloride (HCl)Also: OPANA® ER (oxymorphone HCl) Extended-Release TabletsOpioid | Drug | Pediatric Age Groups: 13 to ≤17 years, Pediatric Age Groups: 7 to ≤12 years |
Primary outcome
Pain Intensity Score using FPS-R
Time frame: 14 Days Post Last Dose
Faces Pain Scale - Revised (FPS-R) self-report measure used to assess pain intensity in participants ages 7 - ≤12 years old, consists of 6 faces, visually representing increasing changes in pain intensity bounded on the left by "no pain" and on the right by "very much pain".
Pain Intensity Score using NRS-11
Time frame: 14 Days Post Last Dose
Numerical Rating Scale (NRS-11) is an 11-point categorical numerical rating scale to assess pain intensity in participants ages 13 - ≤17 years old. The scale is anchored on the left with "No Pain" and is anchored on the right with "Worst Possible Pain".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: Yes
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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.
Saji Vijayan study director
Endo USA Inc., a Keenova Therapeutics Company
5 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 hydrochloride (HCl) in people with Chronic Pain and Postsurgical Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 5 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 11 inclusion and 15 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: paused, as of the sponsor's last update on 23 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 5 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?
Results are not available in the source record.
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?
Pain Intensity Score using FPS-R (time frame: 14 Days Post Last Dose). 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 23 Dec 2020.