NCT02122601

A Clinical Trial to Evaluate the Safety and Efficacy of Retreatment With Intra-articular LBSA0103 Injections in the Patients With Osteoarthritis of the Knee

An Open-label, Single Arm, Multi-center, Phase 3 Study to Evaluate the Safety and Efficacy of Retreatment With Intra-articular LBSA0103 Injections in the Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel) when it is administered for the second time 26 weeks after its first administration in patients with osteoarthritis of the knee. The Safety and efficacy of 26weeks after its first administration will be also evaluated.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DRUG	LBSA0103 (BDDE cross-linked sodium hyaluronate gel)

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-24
• Last updated: 2015-09-09

Locations

1 site across 1 country: South Korea