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Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint

NCT04640961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-12-16

Study results available
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Summary

This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the shoulder joint.

Conditions

  • Osteoarthritis, Shoulder

Interventions

DEVICE

Cingal

Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH).

Sponsors & Collaborators

  • Anika Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kara Mezger · Anika Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-01-16
Primary Completion
2021-09-10
Completion
2021-09-10

Countries

  • Czechia
  • 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 NCT04640961 on ClinicalTrials.gov