At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 192 enrolled
Drug / intervention
MDT-10013 +1 moredrug
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 Phase II, Dose-escalating, Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of MDT-10013 Versus Standard of Care in the Treatment of Acute Postoperative Pain Following Bunionectomy
In Brief
A Phase 2 clinical trial evaluating MDT-10013 and Standard of care for pain for Postoperative Pain. Completed, enrolled 192 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment of acute postoperative pain after subjects undergo bunionectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedMar 2014
Primary CompletionNov 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedMar 4, 2014
Enrollment StartFeb 1, 2014
Primary CompletionNov 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.3 years ago
Interventions
MDT-10013drug
Standard of care for paindrug