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

This study has been completed.
Sponsor:
Information provided by:
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT00450112
First received: March 20, 2007
Last updated: July 25, 2011
Last verified: July 2011
  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
Device: Gel-200
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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: Yes ]

Secondary Outcome Measures:
  • Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    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.

  • Improvement From Baseline in WOMAC VAS (Stiffness Subscore) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    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.

  • Improvement From Baseline in WOMAC VAS (Physical Function Subscore) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    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.

  • Improvement From Baseline in WOMAC VAS (Total Score) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    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.

  • Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response [ Time Frame: Weeks 13 ] [ Designated as safety issue: No ]
    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).

  • Improvement From Baseline in Subject Global Evaluations [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    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.

  • Improvement From Baseline in Physician Global Evaluations [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    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.

  • Acetaminophen Consumption [ Time Frame: Week 9 to Week 13 ] [ Designated as safety issue: No ]
    Weekly mean acetaminophen consumption between weeks 9 and 13.


Enrollment: 202
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Gel-200
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Osamu Akahane, Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT00450112     History of Changes
Other Study ID Numbers: Gel/1132
Study First Received: March 20, 2007
Results First Received: April 15, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014