drug for Broken elbow

N/A

Waitlist Available

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 3, 6 and 12 mfup

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

Patients who present to our institution with a traumatic injury to their elbow who need operative management will be randomized to one of two groups; a treatment arm and a control arm. The treatment arm will receive a three-week postoperative course of indomethacin while the control group will not. We will follow both groups to assess whether or not indomethacin prophylaxis affects the rate of heterotopic ossification.

Eligible Conditions

Broken elbow

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 3, 6 and 12 mfup

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 3, 6 and 12 mfup

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in post operative radiographic evaluation

Secondary study objectives

Disabilities of the Arm, Shoulder and Hand

Patient Rate Elbow Evaluation

The Mayo Elbow Performance score

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: drugExperimental Treatment1 Intervention

The treatment arm will receive 21 days of Indomethacin and Pantoprazole (gastrointestinal protective agent). The patients will receive Indomethacin 25mg three times a day and Pantoprozole 40mg once a day.

Group II: placeboPlacebo Group1 Intervention

The placebo group will receive microcrystalline cellulose powder tablets to be taken as a control. The placebo will be dosed at the same intervals and duration as the treatment arm in this study.

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