A Study for Moderate Osteoarthritis of the Knee — Flexsure  

Osteoarthritis Clinical Trial

Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Centric Study to Determine Whether Flexsure is Safe, Tolerable and Effective in Relieving Symptoms of Moderate Osteoarthritis of the Knee

Status Completed

Clinical Trial Summary

This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.

Clinical Trial Description

Primary efficacy variable:

Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale

Secondary efficacy variables:

• Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale

• Number of patients showing a 20% reduction from baseline in VAS-pain

• Number of patients showing a 50% reduction from baseline in VAS- pain

• Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical function from baseline, as compared to placebo

• Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by daily records in patient diary (First two weeks only)

• Consumption of rescue medication

• Investigator's Global assessment of efficacy

• Subject's global assessment of efficacy ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT01478997
• Study type: Interventional
• Source: Vedic Lifesciences Pvt. Ltd.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2011
• Completion date: March 2012