Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
This study has been terminated.
(Terminated new protocol developed which incorporated Pharmacokinetics)
Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00765856
First received: October 2, 2008
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: Oxymorphone IR - Opioid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- Change in pain intensity from baseline to last assessment using the FPS-R. [ Time Frame: From baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 27 |
| Study Start Date: | October 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Opana® ER
Oxymorphone IR - Opioid
|
Drug: Oxymorphone IR - Opioid
Opana IR 5mg tablet
Other Name: Opana®
|
Detailed Description:
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765856
Locations
| 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 | |
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
| Study Director: | Sr. Director CR&D | Endo Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00765856 History of Changes |
| Other Study ID Numbers: | EN3202 036 |
| Study First Received: | October 2, 2008 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
Opioid tolerant Pediatric Male 6-17 years of age Female 6-17 years of age |
Pain Non malignant Malignant |
Additional relevant MeSH terms:
|
Oxymorphone Analgesics, Opioid Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013