Ibuprofen for Pain in Tibial Fractures

(NSAID Trial)

Recruiting at 13 trial locations

Overseen By Thomas Higgins, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Major Extremity Trauma Research Consortium

Must not be taking: NSAIDs, Aspirin, Glucocorticoids

Disqualifiers: Drug use, Allergy, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Thomas Higgins, MD

Principal Investigator

University of Utah

Renan Castillo, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with tibial shaft fractures. Participants should be experiencing pain and may have conditions like anosognosia or chronic persistent surgical pain. The study excludes those who cannot take NSAIDs due to medical reasons, but specific exclusion criteria are not listed.

Inclusion Criteria

I have a tibia fracture treated with a nail.

I am between 18 and 80 years old.

Patients able to be followed at a METRC facility for at least 12 months following injury

Exclusion Criteria

My consciousness level was below normal when I left the hospital.

I am scheduled for a bone graft during my initial surgery.

I need to take aspirin or NSAIDs, but only take low dose aspirin (81mg).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard pain management with or without NSAIDs for up to 6 weeks

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and union of tibia fractures

12 months

3 visits (in-person) at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ibuprofen

Trial Overview The trial compares standard pain management alone (Group 1) versus standard pain management plus up to six weeks of Ibuprofen, an NSAID (Group 2), in treating tibial fractures. It's a Phase III noninferiority trial conducted across multiple centers.

How Is the Trial Designed?

Group I: Standard of Care Pain Management without NSAIDs Active Control 1 Intervention

Control patients will receive standard of care pain medication regimen and may not use NSAIDs. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs.

Group II: Standard of Care Pain Management with NSAIDs Active Control 1 Intervention

Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials

32

Recruited

27,400+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+