At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 116 enrolled
Drug / intervention
Hydromorphonedrug
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.
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain
In Brief
A Phase 4 clinical trial evaluating Hydromorphone for Postoperative Pain. Completed, enrolled 116 participants across 14 sites.
Detailed Summary
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedApr 2007
Primary CompletionMay 2009
Study CompletionApr 2010
TodayJul 2026
First PostedApr 25, 2007
Enrollment StartApr 1, 2007
Primary CompletionMay 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.2 years ago
Interventions
Hydromorphonedrug
Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.