At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 409 enrolled
Drug / intervention
Tramadol +1 moredrug
Likely dose
Tramadol 25 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 Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
In Brief
A Phase 3 clinical trial evaluating Tramadol and Placebo for Pain Management. Completed, enrolled 409 participants across 5 sites.
Detailed Summary
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Management
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedSep 2017
Primary CompletionApr 2018
Study CompletionApr 2018
TodayJul 2026
First PostedSep 21, 2017
Enrollment StartSep 19, 2017
Primary CompletionApr 11, 2018
Study CompletionApr 23, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.8 years ago
Interventions
Tramadoldrug
IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Placeboother
IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44