Ibuprofen for Fractures, Bone

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Fractures, Bone+2 More
Ibuprofen - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the use of NSAIDs in addition to standard pain management for tibia fractures.

Eligible Conditions
  • Fractures, Bone
  • Fracture

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 3, 6, 12, months

Baseline, 3, 6, 12, months
Pain as assessed by the Brief Pain Inventory (BPI)
Pain interference as assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Physical and Psychosocial functioning as assessed by Patient Report Outcomes Measurement Information System (PROMIS)
Month 12
Numbers of participants with nonunion (secondary surgery to promote union)
Radiographic union as assessed by the modified Radiographic Union Scale in Tibial Fractures (mRUST)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

No NSAIDs
1 of 2
NSAID
1 of 2
Active Control
Experimental Treatment

1000 Total Participants · 2 Treatment Groups

Primary Treatment: Ibuprofen · No Placebo Group · Phase 3

NSAID
Drug
Experimental Group · 1 Intervention: Ibuprofen · Intervention Types: Drug
No NSAIDsNoIntervention Group · 1 Intervention: No NSAIDs · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3, 6, 12, months

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor
28 Previous Clinical Trials
25,511 Total Patients Enrolled
4 Trials studying Fractures, Bone
1,153 Patients Enrolled for Fractures, Bone

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to be followed at a METRC facility for at least 12 months following injury.
Patients who have open or closed tibia fractures treated with a nail.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.