Back to resultsGel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gel-200
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
Inclusion Criteria:
- Previous participation in study SI-6606/01.
Exclusion Criteria:
- Female subjects who are pregnant or lactating.
Sites / Locations
- SKK
Outcomes
Primary Outcome Measures
Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200
Secondary Outcome Measures
Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
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)
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)
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)
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
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
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
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
Weekly mean acetaminophen consumption between weeks 9 and 13.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00450112
Brief Title
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seikagaku Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Gel-200
Intervention Description
Single Intra-articular Injection
Primary Outcome Measure Information:
Title
Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
Description
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.
Time Frame
Baseline and Week 13
Title
Improvement From Baseline in WOMAC VAS (Stiffness Subscore)
Description
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.
Time Frame
Baseline and Week 13
Title
Improvement From Baseline in WOMAC VAS (Physical Function Subscore)
Description
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.
Time Frame
Baseline and Week 13
Title
Improvement From Baseline in WOMAC VAS (Total Score)
Description
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.
Time Frame
Baseline and Week 13
Title
Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response
Description
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).
Time Frame
Weeks 13
Title
Improvement From Baseline in Subject Global Evaluations
Description
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.
Time Frame
Baseline and Week 13
Title
Improvement From Baseline in Physician Global Evaluations
Description
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.
Time Frame
Baseline and Week 13
Title
Acetaminophen Consumption
Description
Weekly mean acetaminophen consumption between weeks 9 and 13.
Time Frame
Week 9 to Week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous participation in study SI-6606/01.
Exclusion Criteria:
Female subjects who are pregnant or lactating.
Facility Information:
Facility Name
SKK
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29780263
Citation
Takamura J, Seo T, Strand V. A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. doi: 10.1177/1179544118773068. eCollection 2018.
Results Reference
derived
PubMed Identifier
27250845
Citation
Strand V, Lim S, Takamura J. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0.
Results Reference
derived
Learn more about this trial
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
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