Gel-200 Versus Placebo in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449696
• Other study ID #: SI-6606/01
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: October 3, 2011
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: October 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Gel-200
Single intra-articular injection
• Placebo
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	Change 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. 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.	Baseline and Week 13	No
Secondary	Change 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. 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.	Baseline and Week 13	No
Secondary	Change 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. 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.	Baseline and Week 13	No
Secondary	Change From Baseline in WOMAC VAS Total Score	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.	Baseline and Week 13	No
Secondary	Outcome Measures in Rheumatology Arthritis 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 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).	Weeks 6 to 13	No
Secondary	Change From Baseline in Short Form - 36 (SF-36)	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.	Baseline and Week 13	No
Secondary	Change 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. 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.	Baseline and Week 13	No
Secondary	Change From Baseline in Physician Global Evaluations	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.	Baseline and Week 13	No
Secondary	Acetaminophen Consumption	Weekly mean acetaminophen consumption between weeks 9 and 13.	Weeks 9 to 13 (5 weeks)	No