ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00450112
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : August 22, 2011
Last Update Posted : August 22, 2011
Sponsor:
Information provided by:
Seikagaku Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee Device: Gel-200 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis


Intervention Details:
  • Device: Gel-200
    Single Intra-articular Injection


Primary Outcome Measures :
  1. Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200 [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. Acetaminophen Consumption [ Time Frame: Week 9 to Week 13 ]
    Weekly mean acetaminophen consumption between weeks 9 and 13.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in study SI-6606/01.

Exclusion Criteria:

  • Female subjects who are pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450112


Locations
United States, Florida
SKK
Plantation, Florida, United States, 33324
Sponsors and Collaborators
Seikagaku Corporation