A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the… (NCT03110523) | Clinical Trial Compass
WithdrawnPhase 3
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Lumbar Spine
Stopped: Strategic business decision
0Started 2023-03-30
Plain-language summary
This is a Phase 3, Multicenter, Randomized, 22 Week, Double-Blind, Placebo Controlled and 3-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of Subjects with Osteoarthritis of the Lumbar Spine. To evaluate the efficacy of X0002 spray compared to placebo for the relief of low back pain disability in subjects with osteoarthritis (OA) of the low back.
Who can participate
Age range35 Years – 85 Years
SexALL
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Inclusion criteria
✓. Must be able to read and to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and applicable regulations, before completing any study related procedures.
✓. Has an understanding, ability, and willingness to fully comply with study procedures and restrictions, as determined by the investigator.
✓. Must be a male or female between 35 and 85 years of age, inclusive.
✓. Must have a body mass index between 18.5 and 40.0 kg/m2, inclusive.
✓. Must have a history (documented diagnosis) of clinically symptomatic OA of the lumbar spine for ≥3 months at Screening.
✓. Must have a Lane Radiographic Grading Scale summary score for lumbar spine OA (levels L1 through L5) of 1 or 2 as determined by a central radiologist at Screening.
✓. Must have had low back pain while standing, walking, and/or on motion for at least 14 days during the month prior to Screening per subject self-report documented by the investigator.
✓. Must have a score ≥4 and ≤9 on a 0 to 10 (11 point) NPRS (without analgesic medication other than rescue medication provided by the Sponsor) over the previous 7 days prior to Baseline (Day 1).
Exclusion criteria
✕. 1\. Not willing to avoid unaccustomed, strenuous physical activity (e.g., starting a new weight lifting routine) for the duration of the study starting at Screening Visit and through their completion of participation in the study. Normal physical activity is allowed.
What they're measuring
1
Average daily Numeric Pain Rating Scale (NPRS) score [0 (no pain) to 10 (worst pain imaginable] for the 7 days prior to Week 12
✕. Has an active or pending workman's compensation claim or litigation related to back pain.
✕. Has secondary OA of the low back or OA of lower limb joints that, in the opinion of the investigator, could interfere with pain and functional assessments related to the low back.
✕. Has a history of spinal surgery.
✕. Has more than 25% improvement from Numeric Pain Rating Scale (NPRS) score at the Screening visit to the average NPRS score over the previous 7 days prior to Day 1.
✕. Has had significant injury, as judged by the investigator, involving the back within the 6 months before Screening.
✕. Has been diagnosed with or has signs and symptoms of a radiculopathy, e.g., numbness or tingling in a dermatomal distribution of a lower limb, sciatica, as well as etiologies of low back pain other than OA.
✕. Has skin lesions or wounds on or near the lumbar spine area to be treated at Screening or on Day 1, which may influence absorption of the medication or confound safety assessments per the investigator's opinion.