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
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Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
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Tracking Information | ||||
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First Submitted Date ICMJE | December 2, 2008 | |||
First Posted Date ICMJE | December 3, 2008 | |||
Results First Submitted Date ICMJE | December 20, 2018 | |||
Results First Posted Date ICMJE | February 27, 2019 | |||
Last Update Posted Date | February 27, 2019 | |||
Actual Study Start Date ICMJE | February 17, 2009 | |||
Actual Primary Completion Date | April 18, 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
During the Single-Dose Period, the safety of oxymorphone IR in children >12-17 years requiring an opioid to treat their acute postoperative pain of various etiologies will be assessed. [ Time Frame: From baseline up to 4 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects. | |||
Official Title ICMJE | 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 | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Postoperative Pain | |||
Intervention ICMJE | Drug: Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Other Name: Opana IR
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Study Arms ICMJE | Experimental: Oxymorphone IR
Open-Label, 2 part ascending-dose multicenter study
Intervention: Drug: Oxymorphone IR
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
58 | |||
Original Estimated Enrollment ICMJE |
48 | |||
Actual Study Completion Date ICMJE | April 18, 2011 | |||
Actual Primary Completion Date | April 18, 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00801398 | |||
Other Study ID Numbers ICMJE | EN3203-010 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Endo Pharmaceuticals | |||
Study Sponsor ICMJE | Endo Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Endo Pharmaceuticals | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |