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NCT04385303 · ClinicalTrials.gov registry record · Phase 3
Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
A Phase 3 study of Knee Osteoarthritis, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 496
- Enrollment target
- 20
- Study locations
NCT04385303: Completed Phase 3 study of Knee Osteoarthritis, sponsored by Biosplice Therapeutics.
NCT04385303 is a Phase 3 study of Knee Osteoarthritis that has completed, run by Biosplice Therapeutics. The registered enrollment target is 496 participants, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04385303, a Phase 3 study of Knee Osteoarthritis, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 496 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
Primary Outcome
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lorecivivint
Study Locations (20)
California
- Research Site - Anaheim
- Research Site - Beverly Hills
- Research Site - Canoga Park
- Research Site - Garden Grove
- Research Site - La Mesa
- Research Site - Norco
- Research Site - Pomona
- Research Site - San Diego
- Research Site - Santa Monica
- Research Site - Thousand Oaks
- Research Site - Westminster
Alabama
- Research Site - Birmingham
- Research Site - Birmingham
- Research Site - Mobile
Arizona
- Research Site - Phoenix
- Research Site - Phoenix
- Research Site - Tucson
Arkansas
- Research Site - Little Rock
Colorado
- Research Site - Boulder
Connecticut
- Research Site - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2021-09-08 |
| Phase | Phase 3 |
What the finished NCT04385303 record still lists
NCT04385303 is an interventional study that assigns participants to a tested intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (65% higher).
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04385303 names 20 study sites across 6 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04385303 about?
NCT04385303 is a clinical study titled "Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)". This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL inject...
What is the current status of trial NCT04385303?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2020-05-26. Estimated completion is 2021-09-08.
What conditions does trial NCT04385303 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT04385303?
The interventions under investigation include: Placebo (DRUG), Lorecivivint (DRUG).
Who is sponsoring clinical trial NCT04385303?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04385303 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Knee Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04385303's enrollment target sits among peer trials
496 8th of 101 higher than 94 of 101 other Knee Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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