Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
ConditionOsteoarthritis Knee Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorSaol Therapeutics Inc
About this trial
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients ≥ 40 years of age
Body Mass Index (BMI) limits
Chronic knee pain resulting from osteoarthritis
Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
Disqualifiers
Non-OA inflammatory arthritis
Confounding elements
Lower limb amputation.
Specified alternate historic treatments
Trial design
Design model
Sequential
Treatments tested in this trial
SL1002
DrugSL1002 injectable solution
Normal Saline
DrugNormal Saline
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: SL1002Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking
The pain intensity score is measured using a numeric rating scale (NRS)
Time frame
Baseline to week 12Sponsors and contacts
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Source ClinicalTrials.gov