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Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain

NCT04231318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2023-08-09

Study results available
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Summary

This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to compare the safety and effectiveness of a single injection of Cingal® to a single injection of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of osteoarthritis of the knee.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Cingal

Single intra-articular injection of Cingal into the knee.

DRUG

Triamcinolone Hexacetonide (TH)

Single intra-articular injection of TH into the knee.

DRUG

Placebo

Single intra-articular injection Placebo (0.9% Saline) into the knee.

Sponsors & Collaborators

  • Anika Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joanne MacFie · Anika Therapeutics

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
2020-09-11
Primary Completion
2022-05-16
Completion
2022-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT04231318 on ClinicalTrials.gov