Trials / Completed
CompletedNCT02077140
A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MDT-10013 | |
| DRUG | Standard of care for pain |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-11-01
- Completion
- 2016-02-01
- First posted
- 2014-03-04
- Last updated
- 2017-10-13
- Results posted
- 2017-10-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02077140. Inclusion in this directory is not an endorsement.