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NCT02536833 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
A Phase 2 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 455
- Enrollment target
NCT02536833: Completed Phase 2 study, sponsored by Biosplice Therapeutics.
NCT02536833 is a Phase 2 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 455 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (242% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02536833, a Phase 2 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of three different strengths of SM04690 injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects.
Primary Outcome
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured
Interventions
- DRUG Placebo
- DRUG SM04690
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2015-09-09 |
| Est. Completion | 2017-04-20 |
| Phase | Phase 2 |
What the finished NCT02536833 record still lists
NCT02536833 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (242% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02536833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02536833 about?
NCT02536833 is a clinical study titled "A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects". The purpose of this study is to assess the efficacy, safety, and tolerability of three different strengths of SM04690 injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects.
What is the current status of trial NCT02536833?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 455 participants. The study started on 2015-09-09. Estimated completion is 2017-04-20.
What interventions are being tested in trial NCT02536833?
The interventions under investigation include: Placebo (DRUG), SM04690 (DRUG).
Who is sponsoring clinical trial NCT02536833?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02536833's enrollment target sits among peer trials
455 85th of 2000 higher than 1,914 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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