Clinical trial NCT00449696: Gel-200 Versus Placebo in Osteoarthritis of the Knee
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 379
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore
timeFrame: Baseline and Week 13
Secondary outcomes:
measure: Change From Baseline in WOMAC VAS Stiffness Subscore
timeFrame: Baseline and Week 13
measure: Change From Baseline in WOMAC VAS Physical Function Subscore
timeFrame: Baseline and Week 13
measure: Change From Baseline in WOMAC VAS Total Score
timeFrame: Baseline and Week 13
measure: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response
timeFrame: Weeks 6 to 13
measure: Change From Baseline in Short Form - 36 (SF-36)
timeFrame: Baseline and Week 13
measure: Change From Baseline in Subject Global Evaluations
timeFrame: Baseline and Week 13
measure: Change From Baseline in Physician Global Evaluations
timeFrame: Baseline and Week 13
measure: Acetaminophen Consumption
timeFrame: Weeks 9 to 13 (5 weeks)
Other outcomes:
Locations:
city: Plantation
country: United States
facility: SKK
state: Florida
Study officials:
References:
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.
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.
citation: Strand V, Baraf HSB, Lavin PT, Lim S, Hosokawa H. A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2012 May;20(5):350-356. doi: 10.1016/j.joca.2012.01.013. Epub 2012 Feb 1.