Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis 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

Qualifiers

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

Treatments tested in this trial

  • SL1002
  • Normal Saline

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

21
California
Sutter Neurology and Pain Management95661, Roseville United States
Innovative Pain Treatment Solutions92111, San Diego United States
Colorado
DBPS Research, LLC80111, Greenwood Village United States
District of Columbia
International Spine, Pain & Performance Center20006, Washington D.C. United States

Sponsors and collaborators

Saol Therapeutics Inc

Lead sponsor