Gel-One Treatment in Knee Osteoarthritis

N/ACompletedNCT01934218

Seikagaku Corporation814 enrolled

Overview

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

814

Conditions

Osteoarthritis Knee

Interventions

Gel-OneDEVICE

PBSDEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a knee pain * Grade 1 to 3 on the Kellgren-Lawrence grading scale Exclusion Criteria: * BMI greater than 35 kg/m2 * Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening * Had a joint replacement of the target knee

Locations (41)

Outcomes

Primary Outcomes

Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26

Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.

Time frame: Baseline up to Week26

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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Sheffield, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Costa Mesa, California, United States

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Garden Grove, California, United States

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North Hollywood, California, United States

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San Diego, California, United States

...and 31 more locations