NCT00750724

Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee

Phase 3 Study GoON and MRI Improvement in OA Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

OA knee is a common degenerative diseases of the joint. * There are many methods to treat this condition. * Hyaluronic acid is one of the recomended treatment of OA knee. * There is no any study on MRI change after injection hyaluronic acid. * The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .

Detailed description

This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with OA of the knee joints. Randomization will be stratified by Kellgren-Lawrence(KL) grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in this study. The study will be conducted over approximately 52 weeks.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	25 mg sodium hyaluronate "GO ON"	25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks
DRUG	normal saline,2 ml., intraarticular weekly for 5 weeks

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2008-09-10
• Last updated: 2010-05-26

Locations

1 site across 1 country: Thailand