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

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ClinicalTrials.gov Identifier: NCT00801398
Recruitment Status : Completed
First Posted : December 3, 2008
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Postoperative Pain
Intervention Drug: Oxymorphone IR
Enrollment 58
Recruitment Details  
Pre-assignment Details  
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
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
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
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
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 13 9 11 9 8 8 58
Hide Baseline Analysis Population Description
ITT Population; Single Dose Total = 33; Multiple Dose Total = 25;
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 9 participants 11 participants 9 participants 8 participants 8 participants 58 participants
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)
[1]
Measure Analysis Population Description: Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 11 participants 9 participants 8 participants 8 participants 58 participants
Female
9
  69.2%
7
  77.8%
8
  72.7%
4
  44.4%
6
  75.0%
4
  50.0%
38
  65.5%
Male
4
  30.8%
2
  22.2%
3
  27.3%
5
  55.6%
2
  25.0%
4
  50.0%
20
  34.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 11 participants 9 participants 8 participants 8 participants 58 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
2
  22.2%
0
   0.0%
1
  12.5%
3
   5.2%
Not Hispanic or Latino
13
 100.0%
9
 100.0%
11
 100.0%
7
  77.8%
8
 100.0%
7
  87.5%
55
  94.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 11 participants 9 participants 8 participants 8 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   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
   0.0%
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
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  15.4%
2
  22.2%
1
   9.1%
0
   0.0%
1
  12.5%
0
   0.0%
6
  10.3%
White
11
  84.6%
7
  77.8%
10
  90.9%
9
 100.0%
7
  87.5%
6
  75.0%
50
  86.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
2
   3.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 9 participants 11 participants 9 participants 8 participants 8 participants 58 participants
13
 100.0%
9
 100.0%
11
 100.0%
9
 100.0%
8
 100.0%
8
 100.0%
58
 100.0%
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Change from Baseline
Change from Baseline
Change from Baseline
Change from Baseline
Change from Baseline
Change from Baseline
Overall Number of Participants Analyzed 13 9 11 9 8 8
Mean (Standard Deviation)
Unit of Measure: mm
15 Minutes Post Dose/ 15 Minutes Post First Dose Number Analyzed 13 participants 9 participants 10 participants 9 participants 8 participants 7 participants
-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 Number Analyzed 13 participants 9 participants 10 participants 9 participants 8 participants 8 participants
-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 Number Analyzed 13 participants 8 participants 10 participants 8 participants 6 participants 8 participants
-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 Number Analyzed 12 participants 4 participants 9 participants 8 participants 4 participants 8 participants
-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 Number Analyzed 10 participants 3 participants 8 participants 4 participants 4 participants 6 participants
-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 Number Analyzed 9 participants 2 participants 4 participants 5 participants 4 participants 6 participants
-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 Number Analyzed 7 participants 5 participants 6 participants 1 participants 3 participants 3 participants
-34.4  (25.32) -3.0  (21.85) -18.2  (18.73) -41.0 [1]   (NA) -6.0  (20.22) -38.3  (9.45)
Multiple Dose #1 Number Analyzed 0 participants 0 participants 0 participants 3 participants 4 participants 5 participants
-28.0  (14.11) -15.0  (17.72) -25.2  (11.65)
Multiple Dose #2 Number Analyzed 0 participants 0 participants 0 participants 2 participants 4 participants 5 participants
-33.5  (10.61) 0.8  (7.04) -17.6  (20.70)
Multiple Dose #3 Number Analyzed 0 participants 0 participants 0 participants 2 participants 2 participants 5 participants
-33.5  (10.61) 4.0  (18.38) -26.4  (12.38)
Multiple Dose #4 Number Analyzed 0 participants 0 participants 0 participants 2 participants 2 participants 5 participants
-33.0  (11.31) 18.5  (13.44) -25.4  (4.04)
Multiple Dose #5 Number Analyzed 0 participants 0 participants 0 participants 2 participants 2 participants 5 participants
-38.0  (4.24) -19.0  (41.01) -21.6  (19.03)
Multiple Dose #6 Number Analyzed 0 participants 0 participants 0 participants 2 participants 1 participants 5 participants
-38.0  (4.24) -1.0 [1]   (NA) -32.8  (15.32)
Multiple Dose #7 Number Analyzed 0 participants 0 participants 0 participants 1 participants 1 participants 5 participants
-33.0 [1]   (NA) -36.0 [1]   (NA) -26.6  (21.80)
Multiple Dose #8 Number Analyzed 0 participants 0 participants 0 participants 1 participants 1 participants 3 participants
-35.0 [1]   (NA) -8.0 [1]   (NA) -32.7  (13.65)
Multiple Dose #9 Number Analyzed 0 participants 0 participants 0 participants 1 participants 1 participants 3 participants
-34.0 [1]   (NA) -6.0 [1]   (NA) -22.7  (15.50)
Multiple Dose #10 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 3 participants
-6.0 -29.0  (17.06)
Multiple Dose #11 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants
-29.0 [1]   (NA) -17.0 [1]   (NA)
Early Termination Number Analyzed 0 participants 0 participants 0 participants 4 participants 5 participants 0 participants
1.8  (50.74) 7.4  (42.29)
[1]
SD cannot be derived based on one subject data point
2.Primary Outcome
Title Subjects Taking Rescue Medication
Hide Description Percentages are based on the number of subjects in each treatment group.
Time Frame first dose through 48 hours after first dose
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 13 9 11 9 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
9
  69.2%
9
 100.0%
7
  63.6%
5
  55.6%
6
  75.0%
4
  50.0%
3.Secondary Outcome
Title AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 6 9 8 6 9
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 3 8 5 5 9
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 6 9 8 6 9
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Tmax: The time at which Cmax was observed
Time Frame Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 6 9 8 6 9
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 3 8 5 5 9
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 3 8 5 5 9
Mean (Standard Deviation)
Unit of Measure: 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)
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.
Adverse Event Reporting Description [Not Specified]
 
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
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/9 (0.00%)   0/11 (0.00%)   0/9 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   1/9 (11.11%)   1/11 (9.09%)   1/9 (11.11%)   1/8 (12.50%)   0/8 (0.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%) 
Eye disorders             
Pupils unequal † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%) 
Vision blurred † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications             
Fat embolism † 1  0/13 (0.00%)  1/9 (11.11%)  0/11 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Failure of implant † 1  0/13 (0.00%)  0/9 (0.00%)  1/11 (9.09%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Investigations             
Somatosensory evoked † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Nervous system disorders             
Headache † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%) 
Monoplegia † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Spinal cord oedema † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Atelectasis † 1  0/13 (0.00%)  1/9 (11.11%)  0/11 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA, Version 11.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/13 (23.08%)   4/9 (44.44%)   7/11 (63.64%)   8/9 (88.89%)   5/8 (62.50%)   6/8 (75.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  3/8 (37.50%) 
Cardiac disorders             
Tachycardia † 1  1/13 (7.69%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%) 
Gastrointestinal disorders             
Abdominal distension † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Constipation † 1  1/13 (7.69%)  0/9 (0.00%)  1/11 (9.09%)  3/9 (33.33%)  4/8 (50.00%)  1/8 (12.50%) 
Nausea † 1  1/13 (7.69%)  2/9 (22.22%)  1/11 (9.09%)  4/9 (44.44%)  2/8 (25.00%)  1/8 (12.50%) 
Vomiting † 1  1/13 (7.69%)  1/9 (11.11%)  0/11 (0.00%)  2/9 (22.22%)  0/8 (0.00%)  1/8 (12.50%) 
General disorders             
Pyrexia † 1  0/13 (0.00%)  0/9 (0.00%)  4/11 (36.36%)  1/9 (11.11%)  0/8 (0.00%)  2/8 (25.00%) 
Investigations             
Oxygen saturation decreased † 1  1/13 (7.69%)  0/9 (0.00%)  0/11 (0.00%)  2/9 (22.22%)  0/8 (0.00%)  2/8 (25.00%) 
Musculoskeletal and connective tissue disorders             
Muscle spasms † 1  1/13 (7.69%)  0/9 (0.00%)  0/11 (0.00%)  0/9 (0.00%)  2/8 (25.00%)  0/8 (0.00%) 
Nervous system disorders             
Dizziness † 1  1/13 (7.69%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  2/8 (25.00%)  1/8 (12.50%) 
Headache † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  3/9 (33.33%)  0/8 (0.00%)  1/8 (12.50%) 
Hypoaesthesia † 1  1/13 (7.69%)  1/9 (11.11%)  0/11 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Sedation † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  1/8 (12.50%) 
Psychiatric disorders             
Anxiety † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%) 
Renal and urinary disorders             
Urinary retention † 1  0/13 (0.00%)  0/9 (0.00%)  1/11 (9.09%)  1/9 (11.11%)  0/8 (0.00%)  3/8 (37.50%) 
Respiratory, thoracic and mediastinal disorders             
Pleural effusion † 1  0/13 (0.00%)  0/9 (0.00%)  0/11 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders             
Pruritus † 1  1/13 (7.69%)  0/9 (0.00%)  0/11 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA, Version 11.1
†
Indicates events were collected by systematic assessment
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Saji Vijayan
Organization: Endo Pharmaceuticals
Phone: (800) 462-3636
EMail: ClinicalTrials@Endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00801398    
Other Study ID Numbers: EN3203-010
First Submitted: December 2, 2008
First Posted: December 3, 2008
Results First Submitted: December 20, 2018
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019