Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450112
• Other study ID #: Gel/1132
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: July 25, 2011
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2011
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Previous participation in study SI-6606/01.

Exclusion Criteria:

• Female subjects who are pregnant or lactating.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Gel-200
Single Intra-articular Injection

Locations

Country	Name	City	State
United States	SKK	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200		13 weeks	Yes
Secondary	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.	Baseline and Week 13	No
Secondary	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.	Baseline and Week 13	No
Secondary	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.	Baseline and Week 13	No
Secondary	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.	Baseline and Week 13	No
Secondary	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).	Weeks 13	No
Secondary	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.	Baseline and Week 13	No
Secondary	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.	Baseline and Week 13	No
Secondary	Acetaminophen Consumption	Weekly mean acetaminophen consumption between weeks 9 and 13.	Week 9 to Week 13	No