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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00449696
Other study ID # SI-6606/01
Secondary ID
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


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
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