Gel-200 Versus Placebo in Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT00449696
First received: March 20, 2007
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
Device: Gel-200
Device: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) in Osteoarthritis of the Knee.

Resource links provided by NLM:


Further study details as provided by Seikagaku Corporation:

Primary Outcome Measures:
  • Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.


Secondary Outcome Measures:
  • Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

  • Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

  • Change From Baseline in WOMAC VAS Total Score [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

  • Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response [ Time Frame: Weeks 6 to 13 ] [ Designated as safety issue: No ]
    Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes 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).

  • Change From Baseline in Short Form - 36 (SF-36) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.

  • Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

  • Change From Baseline in Physician Global Evaluations [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    Observed physician global 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

  • Acetaminophen Consumption [ Time Frame: Weeks 9 to 13 (5 weeks) ] [ Designated as safety issue: No ]
    Weekly mean acetaminophen consumption between weeks 9 and 13.


Enrollment: 379
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gel-200 Device: Gel-200
Single intra-articular injection
Placebo Comparator: PBS Device: Placebo
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:

  • Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

Exclusion Criteria:

  • Subjects with Grade 4 on K-L score
  • Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
  • Serious systemic diseases
  • 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: NCT00449696

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: NCT00449696     History of Changes
Other Study ID Numbers: SI-6606/01
Study First Received: March 20, 2007
Results First Received: April 15, 2011
Last Updated: October 3, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014