Actively Recruiting

Phase 3
Age: 40Years +
All Genders
NCT07226258

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

Led by Saol Therapeutics Inc · Updated on 2026-05-12

150

Participants Needed

20

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients 40 years of age or older
  • Body Mass Index (BMI) within specified limits
  • Chronic knee pain caused by osteoarthritis
  • Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) osteoarthritis
  • Baseline Knee injury and Osteoarthritis Outcome Score (KOOS) pain
  • Patients currently taking baseline analgesics
  • Positive response to diagnostic nerve block
  • Willingness and ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • Presence of non-osteoarthritis inflammatory arthritis
  • Other confounding medical factors
  • Lower limb amputation
  • History of specified alternate treatments
  • Underlying physiological or psychosocial conditions
  • Abnormal Patient Health Questionnaire results
  • Moderate to severe liver impairment
  • Moderate to severe kidney impairment
  • Use of certain baseline medications
  • Inability to comply with study protocol
  • Known allergies or hypersensitivity to study agents
  • History of alcohol or drug abuse
  • Abnormal physical exam findings including ECG or vital signs during screening
  • Abnormal laboratory test results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

Innovative Pain Treatment Solutions

San Diego, California, United States, 92111

Actively Recruiting

2

DBPS Research, LLC

Greenwood Village, Colorado, United States, 80111

Actively Recruiting

3

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, United States, 20006

Actively Recruiting

4

Prime Medical Research

Coral Gables, Florida, United States, 33134

Actively Recruiting

5

Conquest Research, LLC

Orlando, Florida, United States, 32832

Actively Recruiting

6

Conquest Research, LLC

Winter Park, Florida, United States, 32789

Actively Recruiting

7

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

8

Queen City Clinical Research, PLLC

Charlotte, North Carolina, United States, 28211

Actively Recruiting

9

The Center for Clinical Research

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

10

Comprehensive Specialty Care

Edmond, Oklahoma, United States, 73034

Actively Recruiting

11

Pacific Sports and Spine

Eugene, Oregon, United States, 97404

Actively Recruiting

12

University Orthopedics Center

Altoona, Pennsylvania, United States, 16602

Actively Recruiting

13

Pain Diagnostics & Interventional Care LLC

Sewickley, Pennsylvania, United States, 15143

Actively Recruiting

14

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

Actively Recruiting

15

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States, 29601

Actively Recruiting

16

Legent Orthopedic and Spine Hospital

Bellaire, Texas, United States, 77401

Actively Recruiting

17

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States, 78414

Actively Recruiting

18

International Spine, Pain & Performance Center (IPP)

Tyler, Texas, United States, 75701

Actively Recruiting

19

University of Utah Orthopedic Center

Salt Lake City, Utah, United States, 84108

Actively Recruiting

20

Virginia iSpine Physicians, PC

Richmond, Virginia, United States, 23238

Actively Recruiting

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Research Team

K

Kiki Diorgu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain | DecenTrialz