NCT03209362

SI-613 Study for Knee Osteoarthritis

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Seikagaku Corporation · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SI-613	SI-613 will be repeated intra-articularly administered.
COMBINATION_PRODUCT	Placebo	Placebo will be repeated intra-articularly administered.

Timeline

• Start date: 2017-10-19
• Primary completion: 2018-08-17
• Completion: 2018-11-13
• First posted: 2017-07-06
• Last updated: 2021-11-04
• Results posted: 2021-09-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study