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Gel-200 Versus Placebo in Osteoarthritis of the Knee

NCT00449696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2011-10-07

Study results available
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Summary

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Gel-200

Single intra-articular injection

DEVICE

Placebo

Single intra-articular injection

Sponsors & Collaborators

  • Seikagaku Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00449696 on ClinicalTrials.gov