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

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.

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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

Group Type EXPERIMENTAL

SL1002

Intervention Type DRUG

SL1002 injectable solution

Placebo

Normal saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal Saline

Interventions

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SL1002

SL1002 injectable solution

Intervention Type DRUG

Normal Saline

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
7. Diagnostic nerve block response
8. 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