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Repeat Injection of Cingal® for Osteoarthritis of the Knee

NCT02381652 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2022-03-22

Study results available
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Summary

The objective of this study is to evaluate the safety of an injection of Cingal® in subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will be done by a through examination of the incidence of adverse events and physical examination of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

COMBINATION_PRODUCT

Cingal

Injection into the knee

COMBINATION_PRODUCT

Cingal

Injection into the knee

COMBINATION_PRODUCT

Cingal

Injection into the knee

Sponsors & Collaborators

  • Anika Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Laszlo Hangody, MD, PhD, DSc · Semmelweis University, Head of Department of Traumatology

  • Piotr Lukasik, MD, PhD · NZOZ Medi-Spatz

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-04-30
Completion
2015-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Czechia
  • Hungary
  • Poland

Study Locations

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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 NCT02381652 on ClinicalTrials.gov