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Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765856
Recruitment Status : Terminated (Terminated new protocol developed which incorporated Pharmacokinetics)
First Posted : October 3, 2008
Results First Posted : December 16, 2020
Last Update Posted : December 16, 2020
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 Chronic Pain
Intervention Drug: Oxymorphone ER
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxymorphone ER
Hide Arm/Group Description Oxymorphone ER dosage was adjusted by investigator during the titration period. Study was terminated early by the Sponsor.
Period Title: Titration Period
Started 27
Completed 24
Not Completed 3
Period Title: Maintenance Period
Started 24
Completed 18
Not Completed 6
Arm/Group Title Oxymorphone ER
Hide Arm/Group Description Open-label dose titration period of up to 4 weeks and open-label maintenance period of up to 12 weeks.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
14.8  (1.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
15
  55.6%
Male
12
  44.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
3
  11.1%
Not Hispanic or Latino
24
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
23
  85.2%
White
2
   7.4%
More than one race
1
   3.7%
Unknown or Not Reported
1
   3.7%
1.Primary Outcome
Title Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
Hide Description Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants that took at least 1 dose of study medication.
Arm/Group Title Titration Period Maintenance Period
Hide Arm/Group Description:
Open-label dose titration period of up to 4 weeks
Open-label maintenance period of up to 12 weeks
Overall Number of Participants Analyzed 27 24
Mean (Standard Deviation)
Unit of Measure: mg
35.25  (11.955) 39.11  (15.176)
2.Secondary Outcome
Title Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
Hide Description Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants that took at least 1 dose of study medication.
Arm/Group Title Titration Period Maintenance Period
Hide Arm/Group Description:
Open-label dose titration period of up to 4 weeks
Open-label maintenance period of up to 12 weeks
Overall Number of Participants Analyzed 27 24
Mean (Standard Deviation)
Unit of Measure: Tablets
36.1  (15.63) 162.7  (66.77)
3.Secondary Outcome
Title Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
Hide Description Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants that took at least 1 dose of study medication.
Arm/Group Title Titration Period Maintenance Period
Hide Arm/Group Description:
Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure
Open-label maintenance period of up to 12 weeks
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: mg
7.9  (3.01) 5.5  (1.49)
4.Secondary Outcome
Title Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
Hide Description Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants that took at least 1 dose of study medication.
Arm/Group Title Titration Period Maintenance Period
Hide Arm/Group Description:
Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure
Open-label maintenance period of up to 12 weeks
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: Rescue doses/day
1.5  (0.45) 1.1  (0.30)
5.Secondary Outcome
Title Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
Hide Description Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants that took at least 1 dose of study medication.
Arm/Group Title Titration Period Maintenance Period
Hide Arm/Group Description:
Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure
Open-label maintenance period of up to 12 weeks
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: Total number of doses
19.0  (15.36) 17.4  (40.60)
Time Frame First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Titration Period Maintenance Period
Hide Arm/Group Description Open-label dose titration period of up to 4 weeks Open-label maintenance period of up to 12 weeks plus 30 days post-last dose
All-Cause Mortality
Titration Period Maintenance Period
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
Titration Period Maintenance Period
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   3/24 (12.50%) 
Congenital, familial and genetic disorders     
Sickle cell anemia with crisis  1  0/27 (0.00%)  1/24 (4.17%) 
Gastrointestinal disorders     
Acute pancreatitis  1  0/27 (0.00%)  1/24 (4.17%) 
Abdominal pain  1  0/27 (0.00%)  1/24 (4.17%) 
Colitis ulcerative  1  0/27 (0.00%)  1/24 (4.17%) 
Pouchitis  1  0/27 (0.00%)  1/24 (4.17%) 
General disorders     
Pain  1  0/27 (0.00%)  1/24 (4.17%) 
Investigations     
Increased alanine aminotransferase  1  0/27 (0.00%)  1/24 (4.17%) 
Increased aspartate aminotransferase  1  0/27 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/27 (0.00%)  1/24 (4.17%) 
1
Term from vocabulary, MedDRA (11.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Titration Period Maintenance Period
Affected / at Risk (%) Affected / at Risk (%)
Total   15/27 (55.56%)   7/24 (29.17%) 
Gastrointestinal disorders     
Nausea  1  2/27 (7.41%)  1/24 (4.17%) 
General disorders     
Fatigue  1  1/27 (3.70%)  2/24 (8.33%) 
Metabolism and nutrition disorders     
Dehydration  1  0/27 (0.00%)  2/24 (8.33%) 
Nervous system disorders     
Somnolence  1  6/27 (22.22%)  0/24 (0.00%) 
Headache  1  3/27 (11.11%)  2/24 (8.33%) 
Dizziness  1  3/27 (11.11%)  1/24 (4.17%) 
1
Term from vocabulary, MedDRA (11.1)
Indicates events were collected by systematic assessment
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, MBBS
Organization: Endo Pharmaceuticals
Phone: 800-462-3636
EMail: clinicaltrials@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00765856    
Other Study ID Numbers: EN3202 036
First Submitted: October 2, 2008
First Posted: October 3, 2008
Results First Submitted: October 14, 2020
Results First Posted: December 16, 2020
Last Update Posted: December 16, 2020