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Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain

Phase 2
Waitlist Available
Research Sponsored by Xalud Therapeutics, Inc.
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 baseline and up to day 284

Summary

This trial is testing XT-150, a drug given by injection to reduce back pain from inflamed spinal joints. It targets adults with facet joint osteoarthritis who are eligible for standard treatments. XT-150 works by reducing inflammation in the affected joints.

Eligible Conditions
  • Inflammation and Pain
  • Facet Joint Pain
  • Inflammation
  • Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to day 284
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to day 284 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 from Baseline in pain intensity using 0-100 Visual Analog Scale (VAS)
Secondary study objectives
Change from baseline in International Physical Activity Questionnaire (IPAQ short form) scores
Change from baseline in Oswestry Disability Index (ODI) scores
Change from baseline in Patient Global Assessment (PGA) scores
Other study objectives
Change from baseline on Quality of Life

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.45mg XT-150Experimental Treatment1 Intervention
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Group II: 0.15mg XT-150Experimental Treatment1 Intervention
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XT-150
2020
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

Xalud Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
374 Total Patients Enrolled
Perry Tresh, BSStudy DirectorXalud Therapeutics
Howard Rutman, MDStudy DirectorXalud Therapeutics
Morgan StokesStudy DirectorXalud Therapeutics
~20 spots leftby Dec 2025
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