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
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 April 17, 2014