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NCT03122860 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
A Phase 2 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
NCT03122860 is a Phase 2 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 700 participants.
The verdict
NCT03122860, a Phase 2 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
Study Summary
This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).
Interventions
- OTHER Placebo
- OTHER Sham
- DRUG SM04690
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03122860
The ClinicalTrials.gov registry entry for NCT03122860 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosplice Therapeutics, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03122860 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03122860 about?
NCT03122860 is a clinical study titled "A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis". This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based...
What is the current status of trial NCT03122860?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2017-04-24. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT03122860?
The interventions under investigation include: Placebo (OTHER), Sham (OTHER), SM04690 (DRUG).
Who is sponsoring clinical trial NCT03122860?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
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