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Completed

NCT Number: NCT00450112

Gel-200 Extension and Open-Label Study 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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SKK

Plantation, Florida, 33324, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous participation in study SI-6606/01.

Exclusion criteria

  • Female subjects who are pregnant or lactating.

Treatment and study plan

Gel-200

Device

Single Intra-articular Injection

Primary outcomes

  1. Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200

    Time frame: 13 weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 21, 2007
Registry last updated
Aug 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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