NCT01891396

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee

Completed NA Results posted Last updated 30 May 2023

What this trial tests

NA trial testing Hyaluronic Acid and TH (Cingal®) in Knee Osteoarthritis in 368 participants. Completed in 1 September 2014.

Timeline

1 June 2013

Primary endpoint
1 May 2014

1 September 2014

Quick facts

Lead sponsor	Anika Therapeutics, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	368
Start date	1 June 2013
Primary completion	1 May 2014
Estimated completion	1 September 2014
Sites	27 locations across Bulgaria, Canada, Czechia, Hungary, Poland

Drugs / interventions tested

• Hyaluronic Acid and TH (Cingal®)
• Hyaluronic Acid (Monovisc®)
• Saline

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Anika Therapeutics, Inc. — full company profile →

Who can join

Adults 40 to 75, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
  Time frame: 12 Weeks
  The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in p
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP)
  Time frame: 12 Weeks
  The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pa

Sponsor's own description

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial.
   Hangody L, Szody R, Lukasik P, Zgadzaj W, et al · · 2018 · cited 62× · PMID 28535076 · DOI 10.1177/1947603517703732
2. Recent Advances in Clinical Translation of Intra-Articular Osteoarthritis Drug Delivery Systems.
   DeJulius CR, Gulati S, Hasty KA, Crofford LJ, et al · · 2021 · cited 30× · PMID 33709019 · DOI 10.1002/adtp.202000088
3. Cost-Utility of a Single-Injection Combined Corticosteroid-Hyaluronic Acid Formulation vs a 2-Injection Regimen of Sequential Corticosteroid and Hyaluronic Acid Injections.
   Belzile EL, Deakon RT, Vannabouathong C, Bhandari M, et al · · 2017 · cited 11× · PMID 28638242 · DOI 10.1177/1179544117712993
4. Comparison of the 3 Different Injection Techniques Used in a Randomized Controlled Study Evaluating a Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) for Osteoarthritis of the Knee: A Subgroup Analysis.
   McCormack R, Lamontagne M, Vannabouathong C, Deakon RT, et al · · 2017 · cited 4× · PMID 28839449 · DOI 10.1177/1179544117725026