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

Sponsored by:	Seikagaku Corporation
Information provided by:	Seikagaku Corporation
ClinicalTrials.gov Identifier:	NCT00450112

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: Gel-200	Phase III

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.

Further study details as provided by Seikagaku Corporation:

Primary Outcome Measures:

Occurrence of systemic and local adverse events following a single or repeat intra-articular injection of Gel-200 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Examination of the knee, Laboratory tests [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Effectiveness: WOMAC VAS scores (Pain subscore, Stiffness subscore, Physical Function subscore, Total WOMAC score), OMERACT-OARSI Response, SF-36, subject and physician global evaluations, acetaminophen consumption [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Single Intra-articular Injection

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previous participation in study SI-6606/01.

Exclusion Criteria:

Female subjects who are pregnant or lactating.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450112

Locations

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

Sponsors and Collaborators

Seikagaku Corporation

More Information

Responsible Party:	Seikagaku Corporation ( Osamu Akahane )
Study ID Numbers:	Gel/1132
Study First Received:	March 20, 2007
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00450112
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009