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Study Summary
This trial is testing a new drug, XT-150, for people with back pain caused by facet joint osteoarthritis. The drug will be given by injection into the facet joints at the affected level of the spine, and participants will be randomly assigned to receive either the study drug or a placebo. The trial will test the safety and efficacy of two different doses of XT-150.
- Facet Joint Pain
- Inflammation
- Back Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Frequently Asked Questions
Does this trial permit the participation of minors?
"According to the guidelines, this trial is open to all adults aged 18 or above up until 90."
Is it feasible to enroll in this medical experiment?
"This clinical trial seeks seventy-two participants between 18 and 90 years of age with inflammatory symptoms. To be eligible, individuals must identify as male or female, experience Low Back pain that worsens when active, have had a positive diagnostic facet pain block with lidocaine, lack any local or intra-articular infections or tumors causing localized LBP (ex: spondylolysis/pars defect), suffer from osteoarthritis resulting in worst pain at least 50 on the Visual Analog Scale (VAS) 0 to 100 scale; remain on stable analgesic regimen for 4 weeks prior to enrollment; demonstrate inadequate relief from previous therapies"
How many participants are currently receiving treatment as part of this trial?
"Affirmative. Clinicaltrials.gov details confirm that this trial, which was posted on February 24th 2022, is currently open for recruitment. 72 individuals will be included in the study at 3 separate sites."
Is there a possibility for prospective participants to join the trial?
"Affirmative. Information on clinicaltrials.gov confirms that this research trial, which was posted on February 24th 2022, is now recruiting volunteers. A total of 72 subjects need to be recruited from 3 different medical facilities."
Has the FDA granted their stamp of approval to XT-150?
"Our internal evaluation at Power rated XT-150's safety a 2, since the drug has only been subjected to Phase 2 trials with evidence of security but not effectiveness."
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