A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy

ClinicalTrials.gov ID: NCT02077140

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT02077140
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Medtronic Spinal and Biologics; Industry
Enrollment: 192 participants

Conditions and interventions

Conditions

Postoperative Pain

Interventions

MDT-10013 Drug
Standard of care for pain Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 2014 (Type not available)
Primary completion: Nov 2015 (Actual)
Completion: Feb 2016 (Actual)
Last update posted: Oct 13, 2017

2014 – 2016

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Research Site	Phoenix	Arizona	85027	—
Research Site	Austin	Texas	78705	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02077140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 13, 2017 · Synced Nov 13, 2026