Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801398

Enrollment

Registered

2008-12-03

Start date

2009-02-17

Completion date

2011-04-18

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Opioid tolerant, Pediatric, Pain, Non malignant, Malignant

Brief 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. no longer promotes opioids and no longer markets Opana® ER.

Interventions

DRUGOxymorphone IR

Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* Known allergy to, or a significant reaction to, oxymorphone or another opioid * Life expectancy of \< 4 weeks * Positive pregnancy test at screening

Design outcomes

Primary

Measure	Time frame	Description
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	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	first dose through 48 hours after first dose	Percentages are based on the number of subjects in each treatment group.

Secondary

Measure	Time frame	Description
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	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
Cmax of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Tmax of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	Tmax: The time at which Cmax was observed
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	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)
Terminal Half-life of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Single Dose of Oxymorphone IR: 5mg Tablet	13
Single Dose of Oxymorphone IR: 10mg Tablet	9
Single Dose of Oxymorphone IR: 15mg Tablet	11
Multiple Dose of Oxymorphone IR: 5mg Tablet	9
Multiple Dose of Oxymorphone IR: 10mg Tablet	8
Multiple Dose of Oxymorphone IR: 15mg Tablet	8
Total	58

Baseline characteristics

Characteristic	Single Dose of Oxymorphone IR: 5mg Tablet	Total	Multiple Dose of Oxymorphone IR: 15mg Tablet	Multiple Dose of Oxymorphone IR: 10mg Tablet	Multiple Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet
Age, Continuous	14.9 years STANDARD_DEVIATION 1.71	15.07 years STANDARD_DEVIATION 1.44	15.5 years STANDARD_DEVIATION 1.07	15.3 years STANDARD_DEVIATION 1.58	15.0 years STANDARD_DEVIATION 0.71	14.6 years STANDARD_DEVIATION 1.63	15.3 years STANDARD_DEVIATION 1.66
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	3 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	55 Participants	7 Participants	8 Participants	7 Participants	11 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	2 Participants	6 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	50 Participants	6 Participants	7 Participants	9 Participants	10 Participants	7 Participants
Region of Enrollment United States	13 Participants	58 Participants	8 Participants	8 Participants	9 Participants	11 Participants	9 Participants
Sex: Female, Male Female	9 Participants	38 Participants	4 Participants	6 Participants	4 Participants	8 Participants	7 Participants
Sex: Female, Male Male	4 Participants	20 Participants	4 Participants	2 Participants	5 Participants	3 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 9	0 / 11	0 / 9	0 / 8	0 / 8
other Total, other adverse events	3 / 13	4 / 9	7 / 11	8 / 9	5 / 8	6 / 8
serious Total, serious adverse events	0 / 13	1 / 9	1 / 11	1 / 9	1 / 8	0 / 8

Outcome results

Primary

Subjects Taking Rescue Medication

Percentages are based on the number of subjects in each treatment group.

Time frame: first dose through 48 hours after first dose

Population: Safety Population

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	Subjects Taking Rescue Medication	9 Participants
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	Subjects Taking Rescue Medication	9 Participants
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	Subjects Taking Rescue Medication	7 Participants
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	Subjects Taking Rescue Medication	5 Participants
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	Subjects Taking Rescue Medication	6 Participants
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	Subjects Taking Rescue Medication	4 Participants

Primary

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

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

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-34.4 mm	Standard Deviation 25.32
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	3 Hours Post Dose/3 Hours Post First Dose	-35.4 mm	Standard Deviation 26.97
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	2 Hours Post Dose/2 Hours Post First Dose	-19.3 mm	Standard Deviation 29.07
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	15 Minutes Post Dose/ 15 Minutes Post First Dose	-13.4 mm	Standard Deviation 22.86
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	4 Hours Post Dose/4 Hours Post First Dose	-36.2 mm	Standard Deviation 25.03
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	30 Minutes Post Dose/30 Minutes Post First Dose	-12.8 mm	Standard Deviation 36.9
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	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	1 Hour Post Dose/1 Hour Post First Dose	-24.70 mm	Standard Deviation 36.74
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	1 Hour Post Dose/1 Hour Post First Dose	-17.4 mm	Standard Deviation 28.64
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-3.0 mm	Standard Deviation 21.85
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	2 Hours Post Dose/2 Hours Post First Dose	-29.0 mm	Standard Deviation 25.55
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	15 Minutes Post Dose/ 15 Minutes Post First Dose	-22.2 mm	Standard Deviation 17.79
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	30 Minutes Post Dose/30 Minutes Post First Dose	-13.7 mm	Standard Deviation 28.32
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	3 Hours Post Dose/3 Hours Post First Dose	-29.3 mm	Standard Deviation 20.21
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	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	4 Hours Post Dose/4 Hours Post First Dose	-19.5 mm	Standard Deviation 45.96
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-18.2 mm	Standard Deviation 18.73
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	30 Minutes Post Dose/30 Minutes Post First Dose	-22.9 mm	Standard Deviation 19.87
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	1 Hour Post Dose/1 Hour Post First Dose	-29.8 mm	Standard Deviation 20.02
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	15 Minutes Post Dose/ 15 Minutes Post First Dose	-21.6 mm	Standard Deviation 13.59
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	2 Hours Post Dose/2 Hours Post First Dose	-33.8 mm	Standard Deviation 20.1
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	3 Hours Post Dose/3 Hours Post First Dose	-28.6 mm	Standard Deviation 16.75
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	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	4 Hours Post Dose/4 Hours Post First Dose	-31.5 mm	Standard Deviation 14.2
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	15 Minutes Post Dose/ 15 Minutes Post First Dose	-16.7 mm	Standard Deviation 23.31
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Early Termination	1.8 mm	Standard Deviation 50.74
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #9	-34.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	1 Hour Post Dose/1 Hour Post First Dose	-22.0 mm	Standard Deviation 25.13
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #6	-38.0 mm	Standard Deviation 4.24
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	3 Hours Post Dose/3 Hours Post First Dose	-25.8 mm	Standard Deviation 40.17
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #2	-33.5 mm	Standard Deviation 10.61
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #8	-35.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #3	-33.5 mm	Standard Deviation 10.61
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #4	-33.0 mm	Standard Deviation 11.31
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-41.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	4 Hours Post Dose/4 Hours Post First Dose	-34.8 mm	Standard Deviation 31.65
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #5	-38.0 mm	Standard Deviation 4.24
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #7	-33.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	30 Minutes Post Dose/30 Minutes Post First Dose	-18.3 mm	Standard Deviation 25.84
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	Multiple Dose #1	-28.0 mm	Standard Deviation 14.11
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	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	2 Hours Post Dose/2 Hours Post First Dose	-14.4 mm	Standard Deviation 36.56
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #2	0.8 mm	Standard Deviation 7.04
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	15 Minutes Post Dose/ 15 Minutes Post First Dose	0.5 mm	Standard Deviation 9.56
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	1 Hour Post Dose/1 Hour Post First Dose	-7.8 mm	Standard Deviation 18.9
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	2 Hours Post Dose/2 Hours Post First Dose	-6.3 mm	Standard Deviation 22.04
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	3 Hours Post Dose/3 Hours Post First Dose	-15.5 mm	Standard Deviation 19.67
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	4 Hours Post Dose/4 Hours Post First Dose	-7.5 mm	Standard Deviation 29.33
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-6.0 mm	Standard Deviation 20.22
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #1	-15.0 mm	Standard Deviation 17.72
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #3	4.0 mm	Standard Deviation 18.38
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #4	18.5 mm	Standard Deviation 13.44
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #5	-19.0 mm	Standard Deviation 41.01
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #6	-1.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #7	-36.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #8	-8.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #9	-6.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #10	-6.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Multiple Dose #11	-29.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	Early Termination	7.4 mm	Standard Deviation 42.29
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	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	30 Minutes Post Dose/30 Minutes Post First Dose	3.1 mm	Standard Deviation 22.33
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	4 Hours Post Dose/4 Hours Post First Dose	-10.8 mm	Standard Deviation 20.64
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #11	-17.0 mm	—
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #7	-26.6 mm	Standard Deviation 21.8
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	3 Hours Post Dose/3 Hours Post First Dose	-24.7 mm	Standard Deviation 20.7
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	2 Hours Post Dose/2 Hours Post First Dose	-12.9 mm	Standard Deviation 34.37
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #8	-32.7 mm	Standard Deviation 13.65
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	30 Minutes Post Dose/30 Minutes Post First Dose	-23.0 mm	Standard Deviation 15.94
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #9	-22.7 mm	Standard Deviation 15.5
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #3	-26.4 mm	Standard Deviation 12.38
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #2	-17.6 mm	Standard Deviation 20.7
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	1 Hour Post Dose/1 Hour Post First Dose	-28.3 mm	Standard Deviation 15
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #4	-25.4 mm	Standard Deviation 4.04
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #1	-25.2 mm	Standard Deviation 11.65
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #10	-29.0 mm	Standard Deviation 17.06
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #5	-21.6 mm	Standard Deviation 19.03
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-38.3 mm	Standard Deviation 9.45
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	15 Minutes Post Dose/ 15 Minutes Post First Dose	-17.4 mm	Standard Deviation 13.46
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	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	Multiple Dose #6	-32.8 mm	Standard Deviation 15.32

Secondary

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

Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h