Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

August 24, 2022 updated by: Galderma R&D

A Double-blind, Randomized, Multi-centre Study of the Efficacy and Safety of a Single Intra-articular Injection With Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Southhampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoarthritis according to ACR (American College of Radiology) criteria for the knee
  • WOMAC pain score in the range 7 to 17
  • Significant knee pain for the majority of days during the past 3 months
  • Patient normally active, not bedridden or confined to a wheelchair and able to walk 50 meters without the help of a walker, crutches or a cane
  • Patient has attempted but not responded adequately to non-pharmacological therapy(ies)
  • Patient co-operative and able to communicate effectively with the investigators
  • Signed informed consent obtained

Exclusion Criteria:

  • Bilateral knee osteoarthritis
  • Osteoarthritis or clinically significant pain from other part of the musculoskeletal system than the study knee
  • Kellgren Lawrence radiographic score grade IV for the study knee
  • Change in physical therapy/occupational therapy for the knee within the last 3 months
  • Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents for the study knee) during the last week (or 5 half-lives of the drug, whichever is longer) prior to baseline visit
  • Treatment with non-NSAID topicals such as capsaicin for the knee within the last 3 days
  • Intra-articular injection with corticosteroids in the study knee within the last 3 months
  • Use of systemic steroids (excluding inhalation steroids) within the last 3 months
  • Intra-articular injections with hyaluronic acid in the study knee within the last 9 months
  • Treatment with glucosamine/chondroitin sulfate within the last 3 months
  • Treatment with pain relievers except for paracetamol up to 4g/day
  • Treatment with anticoagulant (except for acetylsalicylic acid max. 325 mg/day)
  • Arthroscopy or any other surgical procedure in the study knee within the last 12 months
  • Planned arthroscopy or any other surgical procedure during the study period
  • Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g. severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia)
  • Systemic active inflammatory condition or infection, such as Rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, gout/acute pseudogout or any other connective tissue disease
  • Septic arthritis in the study knee within the last 3 months
  • Active skin disease or infection in the area of the injection site
  • Significant venous or lymphatic stasis present in the legs
  • Pregnant or breast-feeding woman or woman of child-bearing potential not practicing adequate contraception
  • Subjects that in the opinion of the investigator are unsuitable for inclusion (e.g. subjects not likely to avoid other therapies, subjects not likely to stay in the study during the whole study period, or subjects likely to be unreliable)
  • Concurrent participation in any other clinical study or participation within the preceding 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Durolane injection
Intraarticular injection of 3 ml Durolane.
Device: Durolane injection
Placebo Comparator: Saline injection
Intraarticular injection of physiological sodium chloride (0.9% NaCl) solution pH 7.
Other: Saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of responders at 6 weeks.
Time Frame: At 6 weeks after treatment
Proportion of responders was based on the improvement in WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) pain score.
At 6 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC pain score
Time Frame: 2 and 4 weeks after treatment
2 and 4 weeks after treatment
Safety of intraarticular injections of 3 ml Durolane
Time Frame: Through 6 weeks after treatment
Safety was assessed by adverse event soliciting.
Through 6 weeks after treatment
WOMAC stiffness score
Time Frame: 2, 4 and 6 weeks after treatment
2, 4 and 6 weeks after treatment
WOMAC physical function score
Time Frame: 2, 4 and 6 weeks after treatment
2, 4 and 6 weeks after treatment
Patient assessed global status
Time Frame: 2, 4 and 6 weeks after treatment
2, 4 and 6 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Nigel Arden, MD, University Hospital Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35GA0301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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