Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

July 25, 2011 updated by: Seikagaku Corporation

A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.

The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.

Study Overview

Status

Completed

Conditions

Osteoarthritis of the Knee

Intervention / Treatment

Device: Gel-200

Study Type

Interventional

Enrollment (Actual)

202

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Plantation, Florida, United States, 33324
    - SKK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Previous participation in study SI-6606/01.

Exclusion Criteria:

Female subjects who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200 Time Frame: 13 weeks	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore) Time Frame: Baseline and Week 13	Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.	Baseline and Week 13
Improvement From Baseline in WOMAC VAS (Stiffness Subscore) Time Frame: Baseline and Week 13	Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.	Baseline and Week 13
Improvement From Baseline in WOMAC VAS (Physical Function Subscore) Time Frame: Baseline and Week 13	Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.	Baseline and Week 13
Improvement From Baseline in WOMAC VAS (Total Score) Time Frame: Baseline and Week 13	Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.	Baseline and Week 13
Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response Time Frame: Weeks 13	Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).	Weeks 13
Improvement From Baseline in Subject Global Evaluations Time Frame: Baseline and Week 13	Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.	Baseline and Week 13
Improvement From Baseline in Physician Global Evaluations Time Frame: Baseline and Week 13	Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.	Baseline and Week 13
Acetaminophen Consumption Time Frame: Week 9 to Week 13	Weekly mean acetaminophen consumption between weeks 9 and 13.	Week 9 to Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seikagaku Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria