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Ibuprofen for Tibia Fractures

Phase 3

Recruiting

Research Sponsored by Major Extremity Trauma Research Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 18-80 years inclusive

All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 12, months

Awards & highlights

Study Summary

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

Who is the study for?

Adults aged 18-80 with tibia fractures treated with a nail, able to follow up at METRC for 12 months. Excluded are those allergic to NSAIDs, with severe renal failure or bleeding disorders, pregnant/lactating women, and others unable to consent or comply.Check my eligibility

What is being tested?

The trial is testing if adding NSAIDs to standard pain management improves bone healing and reduces opioid use in patients with tibia fractures. It's a randomized study comparing two groups: one receiving NSAIDs for up to six weeks and the other not.See study design

What are the potential side effects?

Possible side effects of taking NSAIDs may include stomach upset or bleeding, kidney problems in those already at risk, allergic reactions, and increased bruising or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have a tibia fracture treated with a nail.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12, months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 12, months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12, months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Numbers of participants with nonunion (secondary surgery to promote union)

Secondary outcome measures

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)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NSAIDExperimental Treatment1 Intervention

Standard of care pain medication regimen with NSAIDs.

Group II: No NSAIDsActive Control1 Intervention

Standard of care pain medication regiment with no NSAIDs

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibuprofen

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor

31 Previous Clinical Trials

26,378 Total Patients Enrolled

Media Library

Ibuprofen Clinical Trial Eligibility Overview. Trial Name: NCT05000281 — Phase 3

Tibia Fracture Research Study Groups: NSAID, No NSAIDs

Tibia Fracture Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT05000281 — Phase 3

Ibuprofen 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000281 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project require participants to be over the age of 50?

"According to the eligibility requirements for this trial, the age range of participants must be between 18 to 80 years old."

Answered by AI

For what sorts of medical conditions is Ibuprofen commonly prescribed?

"Symptoms like catarrh, muscle spasms, and fever can be alleviated by taking Ibuprofen."

Answered by AI

What is the evidence to support Ibuprofen's efficacy?

"There are currently 47 active clinical trials studying Ibuprofen. Phase 3 trials, which are the last step before FDA approval, are ongoing for 11 of those research projects. The majority of the research is happening in Pittsburgh, although there are a total of 95 locations running trials."

Answered by AI

Are we seeking more participants for this research project?

"Yes, this is an ongoing recruitment effort as denoted by the information available on clinicaltrials.gov. The posting went up on 9/14/2021 and was last edited on 10/5/2021. They are hoping to enroll 1000 patients at a single site."

Answered by AI

How large is the test group for this ongoing research project?

"The information available on clinicaltrials.gov affirms that this study is ongoing and recruiting patients. The listing for this trial was created on September 14th, 2021 and was last updated on October 5th, 2021. The study is looking for 1000 participants from a single site."

Answered by AI

Who is eligible to sign up for this research project?

"This study needs to recruit 1000 individuals between 18-80 years old who have suffered a bone fracture. Furthermore, these patients must be able to visit a Major Extremity Trauma & Rehabilitation (METRC) facility for at least 12 months post injury, and have had a nail inserted to treat their fracture."

Answered by AI