Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new injectable drug for knee pain associated with osteoarthritis. The study will enroll a total of 24-108 patients, who will either receive the drug or a placebo. The study will last up to 168 days, including a screening period of up to 28 days.
Eligible Conditions
- Osteoarthritis, Knee Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: Change from baseline to Month 3 in 11 point NRS score
Month 3
Improvement of knee pain
Knee
Day 168
Occurrence of treatment emergent adverse events (TEAEs) overall
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
SL-1002
1 of 2
Matching placebo
1 of 2
Experimental Treatment
Non-Treatment Group
132 Total Participants · 2 Treatment Groups
Primary Treatment: SL-1002 · Has Placebo Group · Phase 2
SL-1002
Drug
Experimental Group · 1 Intervention: SL-1002 · Intervention Types: DrugMatching placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to month 3 in 11 point nrs score
Who is running the clinical trial?
Saol Therapeutics IncLead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Patients currently experiencing continuing pain despite receiving at least 3 months of conservative treatments, inclusive of activity modification, home exercise, protective weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).
You are 35 years of age or older, and have a BMI of 18.0 to 34.9 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.
You have a baseline pain score of ≥ 6 on an 11-point NRS scale as \"usual level of pain over the past 24 hours during weight-bearing activities\" for the index knee.
You have KOOS pain subscale score ≥ 19 and ≤ 67 in the index knee.
You must agree to use the same hormonal contraceptive throughout the study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| District of Columbia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| International Spine, Pain & Performance Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Most responsive sites:
- International Spine, Pain & Performance Center: < 48 hours
Average response time
- < 2 Days
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