Post-Operative PainPhase 3NCT02687451

Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

A Phase 3 study testing Oxymorphone HCl in people with Post-Operative Pain and Acute Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects. Read more about this study

Who is it for?: Ages 0 to 2 years
Conditions the study is for: Post-Operative Pain, Acute Pain
What is being tested?: Oxymorphone HCl
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 3 sitesUnited States
Study dates: Apr 2016to 15 Sep 2020
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 0 to 2 years
All sexes
No healthy volunteers
Child

Who may be able to join

Is male or female <2 years of age at the time of surgery.
Must weigh at least 3 kg.
Is scheduled to have a surgical procedure for which opioid analgesia will be needed to manage postoperative pain for at least 18 hours following intraoperative and/or postoperative IV analgesia.
Is generally healthy as documented by medical history; physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms (EKGs); clinical laboratory assessments; and general observations. Any abnormalities or deviations from the acceptable range that might be considered clinically relevant by the study physician or investigator will be evaluated on a case-by-case basis, agreed upon by the Principal Investigator (or sub-investigator), and documented in study files before enrolling the subject in the study.
The subject's parent or guardian has been informed of the nature of the study and has provided written informed consent.
Postoperative:

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Is anticipated to require an analgesic regimen using a short-acting opioid (non-oxycodone or non-oxymorphone) analgesic after surgery (according to standard of care (SOC) as defined in the protocol).
Is an inpatient expected to be hospitalized for 24 hours after dosing with study drug.
Has an indwelling access catheter for blood sampling.
For Groups A and B: Has demonstrated signs of tolerating oral intake. All infants and children should be able to demonstrate strong suck and swallow reflexes and neurologic alertness and stability sufficient to handle oral secretions.
Prior to administration of oxymorphone HCl oral solution, for Groups A and B, had demonstrated the ability to tolerate clear liquids, following surgery according to the SOC at each institution. All infants and children should be able to demonstrate strong suck and swallow reflexes and neurologic alertness and stability sufficient to handle oral secretions. The ability to tolerate small amounts (1 to 2 oz.) of clear liquids without emesis (over 30 to 60 minutes) would support readiness for study participation and oral intake once the physician has ordered the diet advanced to clear liquids and the subject has ingested fluids by mouth without nausea or vomiting.

Who cannot join

Subjects who meet any of the following criteria will not be eligible to participate in the study:
Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or nervous system(s) or psychiatric disease that would contraindicate participation, as determined by the Investigator.
Has any clinical laboratory test result outside the accepted range that has been confirmed upon re-examination and deemed to be clinically significant.
Has a clinically significant illness or condition any time before dosing with study drug that would contraindicate participation, as determined by the Investigator.
Has a life expectancy <8 weeks.
For age groups A and B: Has a malabsorption, gastroenterologic, or abdominal condition that would interfere with the absorption of study drug.

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Has evidence of increased intracranial pressure.
Has a respiratory condition requiring intubation or resulting in active bronchiolitis, asthma, stridor, or difficulty breathing due to congestion and increased nasal secretions, including oxygen (O2) saturation ≤92%.
Has a history of seizures.
Subject (and/or mother if subject is nursing) has used medications with actions characteristic of monoamine oxidase inhibitors (MAOIs) within 14 days before the start of the study drug is prohibited. Standard daily pediatric multivitamins may be taken until enrollment into the study but will be restricted during the study.
Subject (and/or mother if subject is nursing) has received preoperative opioids for more than 72 consecutive hours.
Subject (and/or mother if subject is nursing) has received oxycodone or oxymorphone within 48 hours prior to screening.
Subject (and/or mother if subject is nursing) has ingested caffeine- or xanthine-containing products (eg, theophylline) within 48 prior to screening. These products are also prohibited during periods when blood samples are collected.
Has a history of relevant drug allergies, food allergies, or both (ie, allergy to oxymorphone or other opioid analgesics) that could interfere with the study.
Parent or legal guardian is unable to provide consent for any reason (eg, mental or physical disabilities, language barriers, or is unavailable).
Subject (and/or mother if subject is nursing) has participated in a clinical study of an unapproved drug within the previous 30 days.
Is not suitable for entry into the study in the opinion of the Investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Endo Clinical Trial Site #1
Dallas, Texas, 75235
Endo Clinical Trial Site #2
Durham, North Carolina, 27710
Endo Clinical Trial Site #4
Houston, Texas, 77030

Other trials in United States

About this study

Official title: An Open-Label Single-Dose And Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Oxymorphone Hydrochloride (HCl) For Acute Moderate To Severe Postoperative Pain In Pediatric Subjects

Conditions: Post-Operative Pain, Acute Pain
Being tested: Oxymorphone HCl, Placebo
Keywords: Surgical Pain, Acute Post-Surgical Pain
Medical subject headings: Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxymorphone HClDrug
Also called Opana
Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).
PlaceboDrug
Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.

Study groups in NCT02687451
Study group	Role	What they receive
Oxymorphone HCl Open-Label Phase	Experimental	Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase. Receives: Drug: Oxymorphone HCl
Oxymorphone HCl Multiple-Dose Phase	Experimental	Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; placebo controlled, randomized, double-blinded multiple-dose phase. Receives: Drug: Oxymorphone HCl
Placebo	Placebo comparator	Sodium Chloride 0.9% solution; comparator for multiple-dose phase. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)
Measured: Up to 24 hours post dose
Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).
Measured: Up to 24 hours post dose

Secondary outcomes (3)

Assessment of Pain Using the Age Appropriate Scale, Face, Legs, Activity, Cry, Consolability (FLACC) or the Neonatal Infant Pain Scale (NIPS).
The Face, Legs, Activity, Cry, Consolability (FLACC) was used for patients between the ages of 6 months and 2 years. The FLACC scale is a validated scale that measures pain in patients who are awake or asleep based on a composite score of observations of facial expression, tonicity in legs, activity scores, the presence of crying, and whether the participant is consolable. Each category is scored on a 0 to 2 scale, which results in a total possible score of 0-10. Assessment of the behavioral score are relaxed and comfortable (0), mild discomfort (1-3), moderate pain (4-6), and severe discomfort/pain (7-10). The Neonatal Infant Pain range from 0-7 The NIPS was used for patients 0 to < 6 months.
Measured: Single Dose Phase: at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours post dose. Multiple Dose Phase: every 0.5 hours up to 24 hours post first dose.
Pharmacokinetic Variable: Volume of Distribution (Vd)
Measured: Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose only
Pharmacokinetic Variable: Clearance (CL)
Measured: Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201615 Sep 2020

First posted22 Feb 2016 (estimated)
Study startApr 2016
Primary completion1 Jul 2020
Study completion15 Sep 2020

Why it stopped: Released from PMR

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 Post-Operative 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02687451
Sponsor's protocol ID: EN3319-304
Status last verified: Jan 2021
First submitted: 14 Jan 2016
Last updated: 26 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
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Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain

All Post-Operative Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Single-Dose And Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Oxymorphone Hydrochloride (HCl) For Acute Moderate To Severe Postoperative Pain In Pediatric Subjects
ClinicalTrials.gov ID: NCT02687451
Acronym / sponsor ID: EN3319-304
Conditions: Post-Operative Pain, Acute Pain
Keywords: Surgical Pain, Acute Post-Surgical Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Released from PMR
Enrolment: 28 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 22 Feb 2016 (estimated)
Results: Posted 26 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Oxymorphone HCl Open-Label Phase	Experimental	Drug: Oxymorphone HClOxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
Oxymorphone HCl Multiple-Dose Phase	Experimental	Drug: Oxymorphone HClOxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; placebo controlled, randomized, double-blinded multiple-dose phase.
Placebo	Placebo comparator	Drug: PlaceboSodium Chloride 0.9% solution; comparator for multiple-dose phase.

Who may qualify

Ages: 0 to 2 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (11 listed)

Is male or female <2 years of age at the time of surgery.
Must weigh at least 3 kg.
Is scheduled to have a surgical procedure for which opioid analgesia will be needed to manage postoperative pain for at least 18 hours following intraoperative and/or postoperative IV analgesia.
Is generally healthy as documented by medical history; physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms (EKGs); clinical laboratory assessments; and general observations. Any abnormalities or deviations from the acceptable range that might be considered clinically relevant by the study physician or investigator will be evaluated on a case-by-case basis, agreed upon by the Principal Investigator (or sub-investigator), and documented in study files before enrolling the subject in the study.
The subject's parent or guardian has been informed of the nature of the study and has provided written informed consent.

Key exclusion criteria (17 listed)

Subjects who meet any of the following criteria will not be eligible to participate in the study:
Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or nervous system(s) or psychiatric disease that would contraindicate participation, as determined by the Investigator.
Has any clinical laboratory test result outside the accepted range that has been confirmed upon re-examination and deemed to be clinically significant.
Has a clinically significant illness or condition any time before dosing with study drug that would contraindicate participation, as determined by the Investigator.
Has a life expectancy <8 weeks.

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 HClAlso: OpanaOral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).	Drug	Oxymorphone HCl Multiple-Dose Phase, Oxymorphone HCl Open-Label Phase
PlaceboPlacebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.	Drug	Placebo

Primary outcome

Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)
Time frame: Up to 24 hours post dose
Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).
Time frame: Up to 24 hours post dose

3 secondary outcomes

Assessment of Pain Using the Age Appropriate Scale, Face, Legs, Activity, Cry, Consolability (FLACC) or the Neonatal Infant Pain Scale (NIPS).
Time frame: Single Dose Phase: at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours post dose. Multiple Dose Phase: every 0.5 hours up to 24 hours post first dose.
Pharmacokinetic Variable: Volume of Distribution (Vd)
Time frame: Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose only
Pharmacokinetic Variable: Clearance (CL)
Time frame: Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose

Results and safety

Results posted to the registry on 26 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (6 Months - <2 Years) 0.05 mg/kg	6	5
Group A (6 Months - <2 Years) 0.10 mg/kg	5	5
Group A (6 Months - <2 Years) 0.15 mg/kg	5	5
Group B (61 Days - <6 Months) 0.10 mg/kg	5	5
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)	4	4
Placebo	3	2

Primary outcome: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)

Time frame: Up to 24 hours post dose. Mean (Standard Deviation). Unit: mg

Measure	Group A (6 Months - <2 Years) 0.05 mg/kg n = 4	Group A (6 Months - <2 Years) 0.10 mg/kg n = 5	Group A (6 Months - <2 Years) 0.15 mg/kg n = 1	Group B (61 Days - <6 Months) 0.10 mg/kg n = 4
Value	3.348 (3.0745)	1.886 (1.5034)	1.400 (NA)	0.725 (0.3797)

Population analysed: Single Dose Safety Population

Primary outcome: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).

Time frame: Up to 24 hours post dose. Mean (Standard Deviation). Unit: mg

Measure	Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years) n = 0	Placebo n = 1
Value	–	0.80 (NA)

Population analysed: Multiple Dose Safety Population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time of informed consent through 14 days after the last dose. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A (6 Months - <2 Years) 0.05 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Group A (6 Months - <2 Years) 0.10 mg/kg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Group A (6 Months - <2 Years) 0.15 mg/kg	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Group B (61 Days - <6 Months) 0.10 mg/kg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Placebo	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Shannon Dalton study director

Endo Pharmceuticals

3 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 HCl in people with Post-Operative Pain and Acute Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 3 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 17 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. Some participants in this study may receive a placebo. 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 26 Oct 2021). 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?

Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose) (time frame: Up to 24 hours post 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?

On the ClinicalTrials.gov record for NCT02687451.

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 26 Oct 2021.

Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (11 listed)

Key exclusion criteria (17 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)

Primary outcome: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).

Adverse events

Research links

Related trials for Post-Operative Pain

Dance Study for Post-surgical Pain in Breast Cancer Survivors

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction

Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty

ESP Blocks for Posterior Spinal Fusion

Referral and contact

Questions about this trial

Keep searching with a free account

Participant flow

Primary outcome: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)

Primary outcome: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).

Adverse events