Cingal for Osteoarthritis, Knee

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Osteoarthritis, Knee+2 More
Cingal - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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, Knee
  • Knee

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 26 Weeks

26 Weeks
Change in baseline WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Cingal
12%Headache
5%Viral upper respiratory tract infection
3%Injection site pain
2%Toothache
2%Upper respiratory tract infection
2%Spinal pain
1%Joint swelling
1%Influenza
1%Injection site reaction
1%Ear Pain
1%Diarrhea
1%Abdominal Pain Upper
1%Pyrexia
1%Bronchitis
1%Laryngitis
1%Back pain
1%Pain in extremity
1%Hypoaesthesia
1%Migraine
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT03191903) in the Cingal ARM group. Side effects include: Headache with 12%, Viral upper respiratory tract infection with 5%, Injection site pain with 3%, Toothache with 2%, Upper respiratory tract infection with 2%.

Trial Design

3 Treatment Groups

Triamcinolone Hexacetonide (TH) - Lederlon
1 of 3
Cingal
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

231 Total Participants · 3 Treatment Groups

Primary Treatment: Cingal · Has Placebo Group · Phase 3

Cingal
Drug
Experimental Group · 1 Intervention: Cingal · Intervention Types: Drug
Triamcinolone Hexacetonide (TH) - Lederlon
Drug
ActiveComparator Group · 1 Intervention: Triamcinolone Hexacetonide - Lederlon · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cingal
2021
Completed Phase 3
~1420

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 26 weeks

Who is running the clinical trial?

Anika Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
2,681 Total Patients Enrolled
5 Trials studying Osteoarthritis, Knee
2,081 Patients Enrolled for Osteoarthritis, Knee

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
and all other analgesics and NSAIDs The subject is willing to use acetaminophen (up to a maximum of 3.0 grams per day) for the treatment of joint pain for the duration of the study
Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products at the same dose throughout the study, if taken prior to signing the ICF.
Some people who have persistent knee pain, limited morning stiffness, and reduced function may have arthritis.
Subject agrees to discontinue all analgesics, except acetaminophen, before their treatment injection and through the completion of the study
The patient has crepitus, restricted movement and bony enlargement.
The subject is able to understand the requirements of the study and agrees to participate voluntarily.
People aged between 40 and 75 are the subject of this text.
The subject has a Kellgren-Lawrence (K-L) severity grade of II or III in the Index knee as determined by X-Ray
Subject must be willing not to have any other treatments for their knee for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.