At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 331 enrolled
Drug / intervention
IV Acetaminophen +1 moredrug
Likely dose
IV Placebo 100 mL solutionfrom 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.
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery
In Brief
A Phase 3 clinical trial evaluating IV Acetaminophen and IV Placebo 100 mL solution for Postoperative Pain and Hysterectomy. Completed, enrolled 331 participants across 27 sites.
Detailed Summary
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Hysterectomy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedNov 2006
Primary CompletionSep 2007
TodayJul 2026
First PostedNov 15, 2006
Enrollment StartNov 1, 2006
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.6 years ago
Interventions
IV Acetaminophendrug
Intravenous acetaminophen 1 g/100 mL
IV Placebo 100 mL solutiondrug
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)