title: 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.
abstract: OBJECTIVE
  To compare the safety and efficacy of a single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control) in a multi-center randomized controlled trial in patients with symptomatic osteoarthritis (OA) of the knee.
  
  
  METHODS
  Patients were randomized 2:1 to receive a single injection of Gel-200 or PBS, after joint aspiration. The primary measure of effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responders, as well as safety of Gel-200.
  
  
  RESULTS
  Of 379 patients randomized, safety was evaluated in 377 and efficacy in 375 (98.9% randomized) in the intent-to-treat population. Effectiveness of Gel-200 by WOMAC pain subscores was statistically significant at week 13 (P=0.037). Mean improvements from baseline in WOMAC pain subscores consistently favored Gel-200 at each visit. Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P<0.05). The number of "strict" OMERACT-OARSI responders was statistically significant from weeks 6 to 13 (P=0.022). Adverse events were not significantly different between treatment groups, including serious adverse events considered related to study treatment.
  
  
  CONCLUSIONS
  This trial demonstrated that a single injection of Gel-200 was well tolerated and relieved pain associated with symptomatic OA of the knee over 13 weeks.
  
  
  BACKGROUND
  ClinicalTrials.gov NTC 00449696.
authors.affiliation: Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
authors.forename: V
authors.initials: V
authors.lastname: Strand
authors.affiliation: The Center for Rheumatology and Bone Research, Wheaton, MD, USA.
authors.forename: H S B
authors.initials: HSB
authors.lastname: Baraf
authors.affiliation: Boston Biostatistics Research Foundation, Framingham, MA, USA.
authors.forename: P T
authors.initials: PT
authors.lastname: Lavin
authors.affiliation: Biostatistics & Data Management Group, Clinical Development Department, Research & Development Division, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Lim
authors.affiliation: Clinical Development Department, Research & Development Division, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan. Electronic address: hiroyuki.hosokawa@seikagaku.co.jp.
authors.forename: H
authors.initials: H
authors.lastname: Hosokawa
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement / Q000379:methods; D012720:Severity of Illness Index; D012965:Sodium Chloride; D016896:Treatment Outcome; D055676:Viscosupplementation / Q000379:methods; D055675:Viscosupplements / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D055675:Viscosupplements; D012965:Sodium Chloride; D006820:Hyaluronic Acid