Trial · NCT01210352

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

NCT01210352, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2019-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects. Trials, record NCT01210352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01210352

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
NCT number: NCT01210352
Status: Completed
Phases: Phase 3
Enrollment: 61 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Post Operative Pain
Interventions: oxymorphone HCl
First posted: 2010-09-28
Last updated: 2021-08-20
Results first posted: 2019-05-07
Limitations and caveats: This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

Source ClinicalTrials.gov

Registered outcomes41

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain).
Primary	Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase	Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Primary	Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase	Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain)
Primary	Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase	0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Primary	Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase	Rescue Medication Use	Rescue Medication Use in Multiple Dose Phase
Secondary	Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Secondary	Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	Tmax: The time at which Cmax was observed
Secondary	Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Secondary	Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	Tlast: The time at which Clast was observed
Secondary	Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule

1 to 10 of 41Source ClinicalTrials.gov

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Outcomes41

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue	Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly.	score on a scale	MEAN
PRIMARY	Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase	Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue	Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly.	score on a scale	MEAN
PRIMARY	Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase	Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue	Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group.	score on a scale	MEAN
PRIMARY	Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase	0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination	Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.	score on a scale	MEAN
PRIMARY	Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase	Rescue Medication Use	Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	PK Population (only including subjects with sufficient evaluable time points for this outcome measure).	ng/mL	MEAN
SECONDARY	Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	PK Population (only including subjects with sufficient evaluable time points for this outcome measure).	h	MEAN
SECONDARY	Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	PK Population (only including subjects with sufficient evaluable time points for this outcome measure).	ng/mL	MEAN
SECONDARY	Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	PK Population (only including subjects with sufficient evaluable time points for this outcome measure).	h	MEAN
SECONDARY	Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose	PK Population (only including subjects with sufficient evaluable time points for this outcome measure).	h*ng/mL	MEAN

1 to 10 of 41Source ClinicalTrials.gov

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Results by group272

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	6 Years to ≤ 12 Years Age Group in Single Dose Phase	Baseline (Prior to Treatment)	4.5	Standard Deviation 3.12	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	2 Years to < 6 Years Age Group in Single Dose Phase	Baseline (Prior to Treatment)	3.4	Standard Deviation 3.55	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	0 Years to < 2 Years Age Group in Single Dose Phase	Baseline (Prior to Treatment)	2.4	Standard Deviation 1.90	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	6 Years to ≤ 12 Years Age Group in Single Dose Phase	15 Minutes Post Dose	3.5	Standard Deviation 3.64	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	2 Years to < 6 Years Age Group in Single Dose Phase	15 Minutes Post Dose	1.2	Standard Deviation 2.50	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	0 Years to < 2 Years Age Group in Single Dose Phase	15 Minutes Post Dose	1.3	Standard Deviation 2.63	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	6 Years to ≤ 12 Years Age Group in Single Dose Phase	30 Minutes Post Dose	2.7	Standard Deviation 3.29	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	2 Years to < 6 Years Age Group in Single Dose Phase	30 Minutes Post Dose	1.2	Standard Deviation 2.28	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	0 Years to < 2 Years Age Group in Single Dose Phase	30 Minutes Post Dose	0.4	Standard Deviation 0.79	score on a scale
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase	6 Years to ≤ 12 Years Age Group in Single Dose Phase	1 Hour Post Dose	1.8	Standard Deviation 1.93	score on a scale

1 to 10 of 272Source ClinicalTrials.gov

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Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg	6
Overall Study	STARTED	Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg	6
Overall Study	STARTED	Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg	7
Overall Study	STARTED	Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg	7
Overall Study	STARTED	Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg	6
Overall Study	STARTED	Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg	6
Overall Study	STARTED	Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg	7
Overall Study	STARTED	Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg	10
Overall Study	STARTED	Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg	6
Overall Study	COMPLETED	Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg	6

1 to 10 of 27Source ClinicalTrials.gov

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Adverse events558

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fall	Injury, poisoning and procedural complications	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg	1	6	1
other	Fall	Injury, poisoning and procedural complications	6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg	0	6	0
other	Fall	Injury, poisoning and procedural complications	6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg	0	7	0
other	Fall	Injury, poisoning and procedural complications	2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg	0	7	0
other	Fall	Injury, poisoning and procedural complications	2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg	0	6	0
other	Fall	Injury, poisoning and procedural complications	2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg	0	6	0
other	Fall	Injury, poisoning and procedural complications	0 to < 2 Years Age Group: Single Dose 0.05 mg/kg	0	7	0
other	Fall	Injury, poisoning and procedural complications	6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg	0	0	0
other	Fall	Injury, poisoning and procedural complications	2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg	0	2	0
other	Postoperative fever	Injury, poisoning and procedural complications	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg	1	6	1

1 to 10 of 558Source ClinicalTrials.gov

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Adverse event totals27

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg	0	6
Total, all-cause mortality	6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg	0	6
Total, all-cause mortality	6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg	0	7
Total, all-cause mortality	2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg	0	7
Total, all-cause mortality	2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg	0	6
Total, all-cause mortality	2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg	0	6
Total, all-cause mortality	0 to < 2 Years Age Group: Single Dose 0.05 mg/kg	0	7
Total, all-cause mortality	6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg	0	10
Total, all-cause mortality	2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg	0	6
Total, other adverse events	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg	5	6

1 to 10 of 27Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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