Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Pain | Drug: Oxymorphone ER | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain. |
Actual Study Start Date : | November 17, 2008 |
Actual Primary Completion Date : | February 22, 2010 |
Actual Study Completion Date : | February 22, 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Oxymorphone ER |
Drug: Oxymorphone ER
Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications Other Name: Opana ER, Opana |
- Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]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.
- Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]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.
- Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]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.
- Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]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.
- Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]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.

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
- Weigh at least 50 kg
- Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Exclusion Criteria:
- Have a life expectancy <4 weeks
- Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
- Have dysphagia or difficulty swallowing whole tablets
- Have a previous exposure to oxymorphone
- Have an ileostomy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765856
United States, Arkansas | |
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine | |
Little Rock, Arkansas, United States, 72202 | |
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
The Children's Hospital | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Connecticut Children's Medical Center | |
Hartford, Connecticut, United States, 06106 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Florida Institute of Medical Research | |
Jacksonville, Florida, United States, 32257 | |
Tukoi Clinical Research | |
Miami, Florida, United States, 34104 | |
St. Joseph's Children's Hospital of Tampa | |
Tampa, Florida, United States, 33618 | |
United States, Georgia | |
Taylor Research, LLC | |
Marietta, Georgia, United States, 30060 | |
United States, Indiana | |
Rehabilitation Associates of Indiana | |
Indianapolis, Indiana, United States, 46250 | |
United States, Kentucky | |
University of Louisville Reserach Foundation, Inc. | |
Louisville, Kentucky, United States, 40202 | |
United States, North Carolina | |
The Center for Clinical Research | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Pennsylvania | |
Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17112 |
Study Director: | Sr. Director CR&D | Endo Pharmaceuticals |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00765856 |
Other Study ID Numbers: |
EN3202 036 |
First Posted: | October 3, 2008 Key Record Dates |
Results First Posted: | December 16, 2020 |
Last Update Posted: | December 16, 2020 |
Last Verified: | November 2020 |
Opioid tolerant Pediatric Male 6-17 years of age Female 6-17 years of age |
Pain Non malignant Malignant |
Chronic Pain Pain Neurologic Manifestations Oxymorphone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia |