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

• Sponsor: Endo Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00801398
• Collaborator: (none)
• Enrollment: 58
• Locations: 11
• Arm: 1
• Actual Duration (Months): 26
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Oxymorphone IR	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
• Actual Study Start Date: Feb 17, 2009
• Actual Primary Completion Date: Apr 18, 2011
• Actual Study Completion Date: Apr 18, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxymorphone IR Open-Label, 2 part ascending-dose multicenter study	Drug: Oxymorphone IR; Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs; Other Names: Opana IR

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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)

6. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
2	Stanford University School of Medicine	Stanford	California	United States	94305
3	The Children's Hospital	Aurora	Colorado	United States	80045
4	Children's Research Institute	Washington	District of Columbia	United States	20010
5	St. Joseph's Children's Hospital of Tampa	Tampa	Florida	United States	33607
6	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
7	Hershey Medical Center	Hershey	Pennsylvania	United States	17033
8	The Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
9	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States	37232
10	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
11	University of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Endo Pharmaceuticals

Investigators

• Study Director: Study Director, Endo Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00801398
• Other Study ID Numbers: EN3203-010
• First Posted: Dec 3, 2008
• Last Update Posted: Feb 27, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Endo Pharmaceuticals: Opioid tolerant; Pediatric; Pain; Non malignant; Malignant
• Additional relevant MeSH terms: Pain, Postoperative; Oxymorphone

Study Results

Participant Flow

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Multiple Dose of Oxymorphone: 5mg Tablet	Multiple Dose of Oxymorphone IR: 10mg Tablet	Multiple Dose of Oxymorphone IR: 15mg Tablet
Arm/Group Description
Period Title: Overall Study
STARTED	13	9	11	9	8	8
COMPLETED	7	0	4	3	1	5
NOT COMPLETED	6	9	7	6	7	3

Baseline Characteristics

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Multiple Dose of Oxymorphone IR: 5mg Tablet	Multiple Dose of Oxymorphone IR: 10mg Tablet	Multiple Dose of Oxymorphone IR: 15mg Tablet	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	13	9	11	9	8	8	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.9 (1.71)	15.3 (1.66)	14.6 (1.63)	15.0 (0.71)	15.3 (1.58)	15.5 (1.07)	15.07 (1.44)
Sex: Female, Male (Count of Participants)
Female	9 69.2%	7 77.8%	8 72.7%	4 44.4%	6 75%	4 50%	38 65.5%
Male	4 30.8%	2 22.2%	3 27.3%	5 55.6%	2 25%	4 50%	20 34.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	2 22.2%	0 0%	1 12.5%	3 5.2%
Not Hispanic or Latino	13 100%	9 100%	11 100%	7 77.8%	8 100%	7 87.5%	55 94.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	2 15.4%	2 22.2%	1 9.1%	0 0%	1 12.5%	0 0%	6 10.3%
White	11 84.6%	7 77.8%	10 90.9%	9 100%	7 87.5%	6 75%	50 86.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	2 25%	2 3.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	13 100%	9 100%	11 100%	9 100%	8 100%	8 100%	58 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet
Arm/Group Description	Change from Baseline	Change from Baseline	Change from Baseline	Change from Baseline	Change from Baseline	Change from Baseline
Measure Participants	13	9	11	9	8	8
15 Minutes Post Dose/ 15 Minutes Post First Dose	-13.4 (22.86)	-22.2 (17.79)	-21.6 (13.59)	-16.7 (23.31)	0.5 (9.56)	-17.4 (13.46)
30 Minutes Post Dose/30 Minutes Post First Dose	-12.8 (36.90)	-13.7 (28.32)	-22.9 (19.87)	-18.3 (25.84)	3.1 (22.33)	-23.0 (15.94)
1 Hour Post Dose/1 Hour Post First Dose	-24.70 (36.74)	-17.4 (28.64)	-29.8 (20.02)	-22.0 (25.13)	-7.8 (18.90)	-28.3 (15.00)
2 Hours Post Dose/2 Hours Post First Dose	-19.3 (29.07)	-29.0 (25.55)	-33.8 (20.10)	-14.4 (36.56)	-6.3 (22.04)	-12.9 (34.37)
3 Hours Post Dose/3 Hours Post First Dose	-35.4 (26.97)	-29.3 (20.21)	-28.6 (16.75)	-25.8 (40.17)	-15.5 (19.67)	-24.7 (20.70)
4 Hours Post Dose/4 Hours Post First Dose	-36.2 (25.03)	-19.5 (45.96)	-31.5 (14.20)	-34.8 (31.65)	-7.5 (29.33)	-10.8 (20.64)
6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-34.4 (25.32)	-3.0 (21.85)	-18.2 (18.73)	-41.0 (NA)	-6.0 (20.22)	-38.3 (9.45)
Multiple Dose #1	-28.0 (14.11)	-15.0 (17.72)	-25.2 (11.65)
Multiple Dose #2	-33.5 (10.61)	0.8 (7.04)	-17.6 (20.70)
Multiple Dose #3	-33.5 (10.61)	4.0 (18.38)	-26.4 (12.38)
Multiple Dose #4	-33.0 (11.31)	18.5 (13.44)	-25.4 (4.04)
Multiple Dose #5	-38.0 (4.24)	-19.0 (41.01)	-21.6 (19.03)
Multiple Dose #6	-38.0 (4.24)	-1.0 (NA)	-32.8 (15.32)
Multiple Dose #7	-33.0 (NA)	-36.0 (NA)	-26.6 (21.80)
Multiple Dose #8	-35.0 (NA)	-8.0 (NA)	-32.7 (13.65)
Multiple Dose #9	-34.0 (NA)	-6.0 (NA)	-22.7 (15.50)
Multiple Dose #10	-6.0	-29.0 (17.06)
Multiple Dose #11	-29.0 (NA)	-17.0 (NA)
Early Termination	1.8 (50.74)	7.4 (42.29)

2. Primary Outcome

Title	Subjects Taking Rescue Medication
Description	Percentages are based on the number of subjects in each treatment group.
Time Frame	first dose through 48 hours after first dose

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Multiple Dose of Oxymorphone: 5mg Tablet	Multiple Dose of Oxymorphone IR: 10mg Tablet	Multiple Dose of Oxymorphone IR: 15mg Tablet
Arm/Group Description	Subjects With at Least One Rescue Medication	Subjects With at Least One Rescue Medication	Subjects With at Least One Rescue Medication	Subjects With at Least One Rescue Medication	Subjects With at Least One Rescue Medication	Subjects With at Least One Rescue Medication
Measure Participants	13	9	11	9	8	8
Count of Participants [Participants]	9 69.2%	9 100%	7 63.6%	5 55.6%	6 75%	4 50%

3. Secondary Outcome

Title	AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
Description	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule
Time Frame	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of 6-OH-Oxymorphone: 5mg Tablet	6-OH-Oxymorphone (ng/mL): 10mg	6-OH-Oxymorphone (ng/mL): 15mg
Arm/Group Description
Measure Participants	9	6	9	8	6	9
Mean (Standard Deviation) [ng*hr/mL]	6.395 (6.0752)	3.766 (2.2587)	67.040 (150.7979)	1.544 (1.8794)	3.040 (1.1625)	7.354 (3.3255)

4. Secondary Outcome

Title	AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group
Description	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

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of 6-OH-Oxymorphone: 5mg Tablet	Single Dose of 6-OH-Oxymorphone: 10mg Tablet	Single Dose 6-OH-Oxymorphone: 15mg Tablet
Arm/Group Description
Measure Participants	9	3	8	5	5	9
Mean (Standard Deviation) [ng*hr/mL]	7.632 (6.6828)	10.223 (6.5195)	109.294 (257.5421)	4.987 (7.5732)	8.692 (10.2430)	12.795 (8.8385)

5. Secondary Outcome

Title	Cmax of Single Dose of Oxymorphone by Treatment Group
Description	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of 6-OH-Oxymorphone: 5mg Tablet	Single Dose of 6-OH-Oxymorphone: 10mg Tablet	Single Dose 6-OH-Oxymorphone: 15mg Tablet
Arm/Group Description
Measure Participants	9	6	9	8	6	9
Mean (Standard Deviation) [ng/mL]	1.243 (1.2192)	0.828 (0.6892)	5.295 (10.6386)	0.314 (0.3276)	0.487 (0.2853)	0.940 (0.5212)

6. Secondary Outcome

Title	Tmax of Single Dose of Oxymorphone by Treatment Group
Description	Tmax: The time at which Cmax was observed
Time Frame	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of 6-OH-Oxymorphone: 5mg Tablet	Single Dose of 6-OH-Oxymorphone: 10mg Tablet	Single Dose 6-OH-Oxymorphone: 15mg Tablet
Arm/Group Description
Measure Participants	9	6	9	8	6	9
Mean (Standard Deviation) [hour]	4.898 (3.9645)	3.681 (2.4102)	6.193 (6.3784)	3.885 (2.7228)	4.631 (3.7051)	3.785 (3.2552)

7. Secondary Outcome

Title	Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group
Description	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)
Time Frame	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of 6-OH-Oxymorphone: 5mg Tablet	Single Dose of 6-OH-Oxymorphone: 10mg Tablet	Single Dose 6-OH-Oxymorphone: 15mg Tablet
Arm/Group Description
Measure Participants	9	3	8	5	5	9
Mean (Standard Deviation) [Time -1]	0.209 (0.2552)	0.214 (0.2962)	0.073 (0.0549)	0.281 (0.2072)	0.101 (0.0965)	0.042 (0.0234)

8. Secondary Outcome

Title	Terminal Half-life of Single Dose of Oxymorphone by Treatment Group
Description	t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)
Time Frame	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Single Dose of 6-OH-Oxymorphone: 5mg Tablet	Single Dose of 6-OH-Oxymorphone: 10mg Tablet	Single Dose 6-OH-Oxymorphone: 15mg Tablet
Arm/Group Description
Measure Participants	9	3	8	5	5	9
Mean (Standard Deviation) [hour]	12.099 (9.9336)	15.900 (18.2533)	19.974 (22.4488)	19.215 (37.3737)	23.635 (33.6381)	22.520 (15.3063)

Adverse Events

Time Frame	All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Arm/Group Title	Single Dose of Oxymorphone IR: 5mg Tablet		Single Dose of Oxymorphone IR: 10mg Tablet		Single Dose of Oxymorphone IR: 15mg Tablet		Multiple Dose of Oxymorphone IR: 5mg Tablet		Multiple Dose of Oxymorphone IR: 10mg Tablet		Multiple Dose of Oxymorphone IR: 15mg Tablet
Arm/Group Description
All Cause Mortality
	Single Dose of Oxymorphone IR: 5mg Tablet		Single Dose of Oxymorphone IR: 10mg Tablet		Single Dose of Oxymorphone IR: 15mg Tablet		Multiple Dose of Oxymorphone IR: 5mg Tablet		Multiple Dose of Oxymorphone IR: 10mg Tablet		Multiple Dose of Oxymorphone IR: 15mg Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Single Dose of Oxymorphone IR: 5mg Tablet		Single Dose of Oxymorphone IR: 10mg Tablet		Single Dose of Oxymorphone IR: 15mg Tablet		Multiple Dose of Oxymorphone IR: 5mg Tablet		Multiple Dose of Oxymorphone IR: 10mg Tablet		Multiple Dose of Oxymorphone IR: 15mg Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		1/9 (11.1%)		1/11 (9.1%)		1/9 (11.1%)		1/8 (12.5%)		0/8 (0%)
Blood and lymphatic system disorders
Anaemia	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Eye disorders
Pupils unequal	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Vision blurred	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Injury, poisoning and procedural complications
Fat embolism	0/13 (0%)		1/9 (11.1%)		0/11 (0%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Failure of implant	0/13 (0%)		0/9 (0%)		1/11 (9.1%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Investigations
Somatosensory evoked	0/13 (0%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Nervous system disorders
Headache	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Monoplegia	0/13 (0%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Spinal cord oedema	0/13 (0%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/13 (0%)		1/9 (11.1%)		0/11 (0%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Single Dose of Oxymorphone IR: 5mg Tablet		Single Dose of Oxymorphone IR: 10mg Tablet		Single Dose of Oxymorphone IR: 15mg Tablet		Multiple Dose of Oxymorphone IR: 5mg Tablet		Multiple Dose of Oxymorphone IR: 10mg Tablet		Multiple Dose of Oxymorphone IR: 15mg Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/13 (23.1%)		4/9 (44.4%)		7/11 (63.6%)		8/9 (88.9%)		5/8 (62.5%)		6/8 (75%)
Blood and lymphatic system disorders
Anaemia	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		0/8 (0%)		3/8 (37.5%)
Cardiac disorders
Tachycardia	1/13 (7.7%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		1/8 (12.5%)		0/8 (0%)
Gastrointestinal disorders
Abdominal distension	0/13 (0%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		1/8 (12.5%)		1/8 (12.5%)
Constipation	1/13 (7.7%)		0/9 (0%)		1/11 (9.1%)		3/9 (33.3%)		4/8 (50%)		1/8 (12.5%)
Nausea	1/13 (7.7%)		2/9 (22.2%)		1/11 (9.1%)		4/9 (44.4%)		2/8 (25%)		1/8 (12.5%)
Vomiting	1/13 (7.7%)		1/9 (11.1%)		0/11 (0%)		2/9 (22.2%)		0/8 (0%)		1/8 (12.5%)
General disorders
Pyrexia	0/13 (0%)		0/9 (0%)		4/11 (36.4%)		1/9 (11.1%)		0/8 (0%)		2/8 (25%)
Investigations
Oxygen saturation decreased	1/13 (7.7%)		0/9 (0%)		0/11 (0%)		2/9 (22.2%)		0/8 (0%)		2/8 (25%)
Musculoskeletal and connective tissue disorders
Muscle spasms	1/13 (7.7%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		2/8 (25%)		0/8 (0%)
Nervous system disorders
Dizziness	1/13 (7.7%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		2/8 (25%)		1/8 (12.5%)
Headache	0/13 (0%)		0/9 (0%)		0/11 (0%)		3/9 (33.3%)		0/8 (0%)		1/8 (12.5%)
Hypoaesthesia	1/13 (7.7%)		1/9 (11.1%)		0/11 (0%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Sedation	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		0/8 (0%)		1/8 (12.5%)
Psychiatric disorders
Anxiety	0/13 (0%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		1/8 (12.5%)		0/8 (0%)
Renal and urinary disorders
Urinary retention	0/13 (0%)		0/9 (0%)		1/11 (9.1%)		1/9 (11.1%)		0/8 (0%)		3/8 (37.5%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/13 (0%)		0/9 (0%)		0/11 (0%)		0/9 (0%)		1/8 (12.5%)		1/8 (12.5%)
Skin and subcutaneous tissue disorders
Pruritus	1/13 (7.7%)		0/9 (0%)		0/11 (0%)		1/9 (11.1%)		1/8 (12.5%)		1/8 (12.5%)

Limitations/Caveats

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.