At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 enrolled
Drug / intervention
Oxymorphone IRdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Oxymorphone IR for Postoperative Pain. Completed, enrolled 58 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartFeb 2009
Primary CompletionApr 2011
TodayJul 2026
First PostedDec 3, 2008
Enrollment StartFeb 17, 2009
Primary CompletionApr 18, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.6 years ago
Interventions
Oxymorphone IRdrug
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs