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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Anika Therapeutics, Inc.
- Enrollment
- 368
- Locations
- 34
- Primary Endpoint
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
Study Overview
Brief Summary
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.
Detailed Description
This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants and Outcomes Assessor were blinded to treatment
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
- •Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.
Exclusion Criteria
- •Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
- •Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).
Outcomes
Primary Outcomes
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 pain. A greater negative difference from baseline means a better outcome.
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 pain. A greater negative difference from baseline means a better outcome.
Secondary Outcomes
- OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)(12 Weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)(3 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)(26 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)(3 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)(3 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP)(3 Week)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)(26 Weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP)(26 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Saline (PP)(26 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Saline (ITT)(26 Weeks)
- Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP).(1 Week)
- Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)(3 Week)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)(3 Weeks)
- OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP)(12 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)(26 Weeks)