Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SL1002, Normal Saline.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Knee Pain. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee
Overview
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
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.
Interventions
- Drug SL1002
SL1002 injectable solution - Drug Normal Saline
Normal Saline
Primary outcome measures
- Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking [Time frame: Baseline to week 12]
Eligibility criteria
Inclusion Criteria includes:
- 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
Exclusion Criteria includes:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- Sutter Neurology and Pain Management — Roseville
- Innovative Pain Treatment Solutions — San Diego
- DBPS Research, LLC — Greenwood Village
- International Spine, Pain & Performance Center — Washington D.C.
- Prime Medical Research — Coral Gables
- Conquest Research, LLC — Orlando
- Conquest Research, LLC — Winter Park
- Mayo Clinic — Rochester
- … and 13 more centers
Identifiers
NCT: NCT07226258 · SL-1010-02