Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
Recruiting
Phase 3Interventional Study
Osteoarthritis Knee Pain
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Saol Therapeutics Inc · Industry
Who this trial is looking for
This trial is looking for adults with chronic knee pain due to osteoarthritis. Participants will receive a single dose of SL1002 to evaluate its effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 40 years old
I have chronic knee pain from osteoarthritis
I have a Kellgren-Lawrence Grade 2 or 3
I have been taking pain relief medications
I have a response to a diagnostic nerve block
You may not be able to join if
I have non-osteoarthritis inflammatory arthritis
I have had a lower limb amputation
I have moderate to severe liver problems
I have moderate to severe kidney problems
I have known allergies to specific agents
I have a history of alcohol or drug abuse
I have abnormal ECG findings or vital sign issues during screening
I have abnormal lab test results
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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Eligibility Criteria
Inclusion Criteria includes:
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 blo…
Inclusion Criteria includes:
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 includes:
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
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