Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.
1 other identifier
interventional
202
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 20, 2007
CompletedFirst Posted
Study publicly available on registry
March 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
August 22, 2011
CompletedAugust 22, 2011
July 1, 2011
2.3 years
March 20, 2007
April 15, 2011
July 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200
13 weeks
Secondary Outcomes (8)
Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
Baseline and Week 13
Improvement From Baseline in WOMAC VAS (Stiffness Subscore)
Baseline and Week 13
Improvement From Baseline in WOMAC VAS (Physical Function Subscore)
Baseline and Week 13
Improvement From Baseline in WOMAC VAS (Total Score)
Baseline and Week 13
Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response
Weeks 13
- +3 more secondary outcomes
Interventions
Single Intra-articular Injection
Eligibility Criteria
You may qualify if:
- Previous participation in study SI-6606/01.
You may not qualify if:
- Female subjects who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SKK
Plantation, Florida, 33324, United States
Related Publications (2)
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.
PMID: 29780263DERIVEDStrand 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.
PMID: 27250845DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Dept.
- Organization
- Seikagaku Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2007
First Posted
March 21, 2007
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
August 22, 2011
Results First Posted
August 22, 2011
Record last verified: 2011-07