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A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis

NCT03200288 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2021-11-16

No results posted yet for this study

Summary

This is a study to evaluate the Clinical Performance and Safety of a single intra-articular (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to osteoarthritis (OA) of the knee.

Conditions

Interventions

DEVICE

HL-01: high and low molecular weight hyaluronic acid

2 ml intra-articular single injection

DEVICE

Placebo

2 ml intra-articular single injection

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2018-06-27
Completion
2018-10-30

Countries

  • Belgium
  • Germany
  • Hungary
  • Italy
  • 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 NCT03200288 on ClinicalTrials.gov