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NCT07006675 · ClinicalTrials.gov registry record · Phase 3

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

A Phase 3 study of Pain and Tibial Fractures, sponsored by Major Extremity Trauma Research Consortium.

Recruiting
Registry status
Phase 3
Development phase
1,000
Enrollment target
14
Study locations

NCT07006675 is a Phase 3 study of Pain and Tibial Fractures that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 1,000 participants, above the 302-participant average among 374 other Pain trials with a reported enrollment target (231% higher). The trial reports 14 study locations across 13 states.

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The verdict

NCT07006675, a Phase 3 study of Pain and Tibial Fractures, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.

RECRUITING
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target
14
Study locations

Study Summary

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Conditions Studied

Pain Tibial Fractures

Interventions

  • DRUG 600 mg Ibuprofen

Study Locations (14)

Indiana

  • Eskenazi Hospital - Indianapolis
  • Indiana University-Methodist - Indianapolis

Maryland

  • University of Maryland R Adams Cowley Shock Trauma Center - Baltimore

Massachusetts

  • Harvard Medical Center - Cambridge

Minnesota

  • Hennepin Health - Minneapolis

Mississippi

  • University of Mississippi - Jackson

Ohio

  • The MetroHealth System - Cleveland

Pennsylvania

  • Allegheny General Hospital - Pittsburgh

Tennessee

  • Vanderbilt Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2021-05-26
Est. Completion 2027-03
Phase Phase 3

Sponsor

Major Extremity Trauma Research Consortium

30 total trials

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What the Registry Record Tells You About NCT07006675

The ClinicalTrials.gov registry entry for NCT07006675 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 302-participant average among 374 other Pain trials with a reported enrollment target (231% higher). The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which 600 mg Ibuprofen is the first listed.

NCT07006675 reports 14 study locations spanning 13 distinct geographic areas - top geographies include Indiana, Maryland, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07006675 about?

NCT07006675 is a clinical study titled "Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial". Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

What is the current status of trial NCT07006675?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2021-05-26. Estimated completion is 2027-03.

What conditions does trial NCT07006675 study?

This clinical trial studies the following conditions: Pain, Tibial Fractures.

What interventions are being tested in trial NCT07006675?

The interventions under investigation include: 600 mg Ibuprofen (DRUG).

Who is sponsoring clinical trial NCT07006675?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07006675 being conducted?

This trial has 14 study locations across Indiana, Maryland, Massachusetts, Minnesota, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.