This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints. Study drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA) injection into the facet capsule, at the affected spinal level (e.g. Lumbar \[L\]3-4, L4-5, or L5-Sacrum \[S\]1) as determined by imaging (e.g., Magnetic resonance imaging \[MRI\], Computed tomography \[CT\]), X-ray, etc.) and physical exam. Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24 participants per treatment group). 1. 0.15 mg XT-150 (1.0 milliliter \[mL\] total delivered by two 0.5 mL injections) 2. 0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections) 3. Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Neurovations
Napa, California, United States
Source HealthCare
Santa Monica, California, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Time frame: Up to Day 270
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Hematology and chemistry samples were only collected at Screening and not retested; therefore no results are available for those assessments Abnormal clinically significant physical examination findings were reported as adverse events, as applicable, and not separately reported. Vital signs of temperature, heart rate, respiratory rate and blood pressure were collected at all visits throughout the study.
Time frame: Up to Day 270
Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS)
The VAS is 0-100 scale which will be administered to participants via Electronic Patient Reported Outcome (ePRO) at each study visit. The participant will record his/her facet pain level on a scale from 0 (no pain) to 100 (worst pain). Higher scores indicate worse pain intensity.
Time frame: Day 270
Change From Baseline in Oswestry Disability Index (ODI) Scores
The Oswestry Disability Index (ODI) is a 10-item questionnaire to quantify disability for acute or chronic low back pain. Each question is scored on a scale of 0 (least amount of disability) to 5 (most severe disability). Higher scores indicate severe disability.
Time frame: Day 270
Change From Baseline in Patient Global Assessment (PGA) Scores
PGA is used to assess the current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). Higher score indicates worse symptoms.
Time frame: Up to Day 270
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores
The globally standardized and validated IPAQ - short form is used to measure self-reported physical activity levels. Four metabolic equivalent tasks (MET) - vigorous, moderate, walking and sitting were included to obtain the physical activity levels from the participants. A higher MET value indicates a higher physical activity level.
Time frame: Day 270
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