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Antipsychotic

Haloperidol for Back Pain

Phase 4
Recruiting
Led By Jessica McCoy, MD
Research Sponsored by Western Michigan University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 65 years old
Presenting to the Bronson ED with a chief complaint of acute, non-traumatic back pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 60, and 90 minutes after drug administration
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will involve 150 patients aged 18-65 who come to the emergency department with back pain. The patients will be randomly assigned to different groups, and their symptoms will be monitored at

Who is the study for?
This trial is for adults aged 18-65 who come to the Bronson ED with acute, non-traumatic back pain and a pain score over 5 cm. It's not suitable for those outside this age range or with different types of back pain.
What is being tested?
The study tests Haloperidol against Ketorolac Tromethamine for managing acute musculoskeletal back pain in the ED. Patients are randomly assigned to either drug, and their symptoms are tracked at intervals up to 90 minutes, with a follow-up call after 24 hours.
What are the potential side effects?
Possible side effects may include drowsiness, dry mouth, blurred vision from Haloperidol; while Ketorolac might cause stomach upset, bleeding risk increase or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I went to the ER because my back suddenly started hurting without any injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 60, and 90 minutes after drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 60, and 90 minutes after drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual Analog Scale (VAS)
Secondary study objectives
Length of stay after enrollment
Need for rescue medications
Patient Satisfaction

Side effects data

From 2016 Phase 4 trial • 35 Patients • NCT02199743
21%
Insomnia
21%
Sedation
14%
Stiffness in jaw
7%
diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lurasidone (LUR)
NONLUR

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HaloperidolExperimental Treatment1 Intervention
Haloperidol 5 mg IM haloperidol
Group II: KetoralacActive Control1 Intervention
Ketoralac 30 mg IM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Haloperidol
2013
Completed Phase 4
~1238310

Find a Location

Who is running the clinical trial?

Western Michigan University School of MedicineLead Sponsor
5 Previous Clinical Trials
484 Total Patients Enrolled
Bronson Methodist HospitalUNKNOWN
1 Previous Clinical Trials
114 Total Patients Enrolled
Jessica McCoy, MDPrincipal InvestigatorWestern Michigan University Homer Stryker M.D. School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled
~33 spots leftby Apr 2025
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