NCT07226258

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
10mo left

Started Nov 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Nov 2025Feb 2027

First Submitted

Initial submission to the registry

November 6, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

November 6, 2025

Last Update Submit

March 24, 2026

Conditions

Osteoarthritis Knee Pain

Outcome Measures

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)

    Baseline to week 12

Study Arms (2)

SL1002

EXPERIMENTAL

SL1002

Drug: SL1002

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Normal Saline

Interventions

SL1002DRUG

SL1002 injectable solution

SL1002
Normal SalineDRUG

Normal Saline

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Baseline KOOS pain
  • Patients taking baseline analgesics
  • Diagnostic nerve block response
  • Compliance with identified study requirements

You may not qualify if:

  • Non-OA inflammatory arthritis
  • Confounding elements
  • Lower limb amputation.
  • Specified alternate historic treatments
  • Identified underlying physiologic or psychosocial conditions
  • Patient Health Questionnaire
  • Moderate to severe hepatic impairment
  • Moderate to severe renal impairment
  • Identifiable baseline medications
  • Protocol compliance requirements
  • Known allergies or hypersensitivity to identified agents
  • Identified alcohol or drug abuse history
  • Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
  • Identified underlying abnormal laboratory results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Innovative Pain Treatment Solutions

San Diego, California, 92111, United States

RECRUITING

DBPS Research, LLC

Greenwood Village, Colorado, 80111, United States

RECRUITING

International Spine, Pain & Performance Center

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

RECRUITING

Prime Medical Research

Coral Gables, Florida, 33134, United States

RECRUITING

Conquest Research, LLC

Orlando, Florida, 32832, United States

RECRUITING

Conquest Research, LLC

Winter Park, Florida, 32789, United States

RECRUITING

Queen City Clinical Research, PLLC

Charlotte, North Carolina, 28211, United States

RECRUITING

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Comprehensive Specialty Care

Edmond, Oklahoma, 73034, United States

RECRUITING

Pacific Sports and Spine

Eugene, Oregon, 97404, United States

RECRUITING

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

RECRUITING

Pain Diagnostics & Interventional Care LLC

Sewickley, Pennsylvania, 15143, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

RECRUITING

Legent Orthopedic and Spine Hospital

Bellaire, Texas, 77401, United States

RECRUITING

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

RECRUITING

International Spine, Pain & Performance Center (IPP)

Tyler, Texas, 75701, United States

RECRUITING

Virginia iSpine Physicians, PC

Richmond, Virginia, 23238, United States

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Kiki Diorgu, M.D.

CONTACT

770-274-2827info@saolrx.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2025

First Posted

November 10, 2025

Study Start

November 7, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(18)