At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 854 enrolled
Drug / intervention
Morphine +4 moredrug
Likely dose
Morphine 20 mgfrom 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 Randomized, Double-blind, Parallel-arm, Placebo- and Comparator- Controlled Trial of the Efficacy and Safety of Multiple Doses of Immediate-release (IR) CG5503 for Postoperative Pain Following Abdominal Hysterectomy
In Brief
A Phase 3 clinical trial evaluating Morphine, CG5503 IR, and 1 other intervention for Hysterectomy and Postoperative. Completed, enrolled 854 participants across 52 sites in 9 countries.
Detailed Summary
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHysterectomy, Postoperative
CountriesHungary, Latvia, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Ukraine
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionFeb 2008
Study CompletionApr 2008
TodayJul 2026
First PostedMay 24, 2007
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.1 years ago
Interventions
Morphinedrug
20 mg IR; 4 - 6 hourly; Total 72 hours
CG5503 IRdrug
50mg; 4 - 6 hourly; Total 72 hours
CG5503 IRdrug
75mg; 4 -6 hourly; Total 72 hours
CG5503 IRdrug
100mg, 4 - 6 hourly; Total 72 hours
Placebodrug
4 - 6 hourly; Total 72 hours