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

NCT ID: NCT07226258

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.

Conditions

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Osteoarthritis Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SL1002

SL1002

Group Type EXPERIMENTAL

SL1002

Intervention Type DRUG

SL1002 injectable solution

Placebo

Normal saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

SL 1002

Interventions

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SL1002

SL1002 injectable solution

Intervention Type DRUG

Normal Saline

SL 1002

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients ≥ 40 years of age
2. Body Mass Index (BMI) limits
3. Chronic knee pain resulting from osteoarthritis
4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
5. Baseline KOOS pain
6. Patients taking baseline analgesics

9\. Diagnostic nerve block response 10. Compliance with identified study requirements

Exclusion Criteria

1. Non-OA inflammatory arthritis
2. Confounding elements
3. Lower limb amputation.
4. Specified alternate historic treatments
5. Identified underlying physiologic or psychosocial conditions
6. Patient Health Questionnaire
7. Moderate to severe hepatic impairment
8. Moderate to severe renal impairment
9. Identifiable baseline medications
10. Protocol compliance requirements
11. Known allergies or hypersensitivity to identified agents
12. Identified alcohol or drug abuse history
13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
14. Identified underlying abnormal laboratory results
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saol Therapeutics Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DBPS Research, LLC

Greenwood Village, Colorado, United States

Site Status RECRUITING

International Spine, Pain & Performance Center

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

Site Status RECRUITING

Prime Medical Research

Coral Gables, Florida, United States

Site Status RECRUITING

Conquest Research, LLC

Orlando, Florida, United States

Site Status RECRUITING

Conquest Research, LLC

Winter Park, Florida, United States

Site Status RECRUITING

Queen City Clinical Research, PLLC

Charlotte, North Carolina, United States

Site Status RECRUITING

Pacific Sports and Spine

Eugene, Oregon, United States

Site Status RECRUITING

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States

Site Status RECRUITING

HD Research, First Surgical Hospital (FSH)

Bellaire, Texas, United States

Site Status RECRUITING

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States

Site Status RECRUITING

Virginia iSpine Physicians, PC

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Scott Bainbridge, MD

Role: primary

Mehul Desai, MD

Role: primary

Miquel Telleria, M.D.

Role: primary

Jorge Fernandez-Silva, M.D.

Role: primary

Anand Patel, M.D.

Role: primary

Christopher Gilmore, M.D.

Role: primary

Gregory Moore, M.D.

Role: primary

Brian Jakubowicz, M.D.

Role: primary

Daneshvari Solanki, MD

Role: primary

Mitchell Engle, M.D.

Role: primary

Michael DePalma, MD

Role: primary

Other Identifiers

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SL-1010-02

Identifier Type: -

Identifier Source: org_study_id