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Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide

NCT03191903 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2022-02-24

Study results available
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Summary

This is a multi-center, randomized, double-blind, parallel group, active comparator controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the relief of joint pain in subjects with OA of the knee.

Conditions

Interventions

COMBINATION_PRODUCT

Cingal

Hyaluronic Acid with Triamcinolone Hexacetonide

DEVICE

Monovisc

Hyaluronic acid

DRUG

Triamcinolone Hexacetonide

Triamcinolone Hexacetonide

Sponsors & Collaborators

  • Anika Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Laszlo Hangody, MD · Uzsoki Hospital, Department of Traumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2018-04-23
Completion
2018-04-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03191903 on ClinicalTrials.gov