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NCT02077140 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Medtronic Spinal and Biologics.

Completed
Registry status
Phase 2
Development phase
192
Enrollment target

NCT02077140: Completed Phase 2 study, sponsored by Medtronic Spinal and Biologics.

NCT02077140 is a Phase 2 study that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 192 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02077140, a Phase 2 study, has completed, sponsored by Medtronic Spinal and Biologics.

COMPLETED
Registry status
Phase 2
Development phase
192 participants
Enrollment target

Study 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.

Primary Outcome

Summed pain intensity is a time-weighted average pain score in numeric rating scale (NRS) over 1 to 48hrs (SPI-48). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours). The theoretical range for SPI-48 is 0 to 470, with lower scores indicative of less pain over this time period (i.e., lower scores are

Interventions

  • DRUG MDT-10013
  • DRUG Standard of care for pain

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2014-02
Est. Completion 2016-02
Phase Phase 2
Medtronic Spinal and Biologics

26 total trials

What the finished NCT02077140 record still lists

NCT02077140 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).

The record links to 0 conditions, and to 2 interventions - of which MDT-10013 is the first listed.

NCT02077140 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02077140 about?

NCT02077140 is a clinical study titled "A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy". 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 ...

What is the current status of trial NCT02077140?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2014-02. Estimated completion is 2016-02.

What interventions are being tested in trial NCT02077140?

The interventions under investigation include: MDT-10013 (DRUG), Standard of care for pain (DRUG).

Who is sponsoring clinical trial NCT02077140?

This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02077140's enrollment target sits among peer trials

192 352nd of 2000 higher than 1,648 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02077140, the US trial registry maintained by the National Library of Medicine. NCT02077140 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.