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Cingal for Osteoarthritis

Phase 3
Waitlist Available
Research Sponsored by Anika Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study Summary

This trial is testing whether a steroid injection provides more pain relief than a placebo when used to treat osteoarthritis of the knee.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
Secondary outcome measures
Change From Baseline in Knee Pain as Measured by Numerical Rating Scale (NRS) Pain Score
Change From Baseline in Knee Pain as Measured by Visual Analog Scale (VAS) Pain Score
Change From Baseline in the Evaluator Global Assessment (EGA) Score
+6 more

Side effects data

From 2018 Phase 3 trial • 576 Patients • NCT03191903
12%
Headache
5%
Viral upper respiratory tract infection
3%
Injection site pain
2%
Spinal pain
2%
Upper respiratory tract infection
2%
Toothache
1%
Pyrexia
1%
Hypoaesthesia
1%
Abdominal Pain Upper
1%
Bronchitis
1%
Influenza
1%
Laryngitis
1%
Ear Pain
1%
Diarrhea
1%
Injection site reaction
1%
Back pain
1%
Pain in extremity
1%
Migraine
1%
Joint swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cingal
Monovisc
Triamcinolone Hexacetonide (TH)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CingalExperimental Treatment1 Intervention
Single injection of Cingal: 4 milliliter (mL) dose of 88 mg (22 mg/mL) of cross-linked sodium hyaluronate with 18 mg (4.5 mg/mL) of triamcinolone hexacetonide (TH). Manufactured by Anika Therapeutics.
Group II: Triamcinolone Hexacetonide (TH)Active Control1 Intervention
Single injection of Triamcinolone Hexacetonide (TH): 1 milliliter (mL) dose of 20 mg/ml TH. Manufactured by IntraPharm.
Group III: PlaceboPlacebo Group1 Intervention
Single injection of Placebo: 4 milliliter (mL) dose of 0.9% saline. Manufactured by Anika Therapeutics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cingal
2020
Completed Phase 3
~1750

Find a Location

Who is running the clinical trial?

Anika Therapeutics, Inc.Lead Sponsor
17 Previous Clinical Trials
2,691 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,331 Patients Enrolled for Osteoarthritis
Joanne MacFieStudy DirectorAnika Therapeutics
3 Previous Clinical Trials
75 Total Patients Enrolled
3 Trials studying Osteoarthritis
75 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain
2020. "Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04231318.
~50 spots leftby Apr 2025
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