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Durolane Versus Methylprednisolone in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01209364
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Durolane is a device, methylprednisolone in a drug Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee
Study Start Date : March 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Durolane
intraarticular hyaluronic acid
 Device: Durolane is a device, methylprednisolone in a drug
single intraarticular injection
Other Name: Durolane and Depo-Medrol are the brand names
Active Comparator: methylprednisolone
intraarticular injection
 Device: Durolane is a device, methylprednisolone in a drug
single intraarticular injection
Other Name: Durolane and Depo-Medrol are the brand names


Outcome Measures
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Primary Outcome Measures :
  1. Pain level and responder rate [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. WOMAC stiffness score [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ]
    Will be assessed at each clinic visit

  2. WOMAC physical function [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ]
    Will be assessed at each clinic visit

  3. Functional assessment [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ]
    Will be assessed at each clinic visit

  4. Safety assessment (Adverse Events) [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ]
    Will be assessed at each clinic visit using standard questions


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject (female or male) 35-80 years of age
  • Unilateral knee pain
  • Radiographic evidence of OA
  • WOMAC pain score of 7-17
  • Subject normally active
  • Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
  • Subject cooperative and able to communicate effectively with the investigators;
  • Body mass index ≤ 40 kg/m2;
  • Signed informed consent obtained.

Exclusion Criteria:

  • Knee effusion
  • Contralateral knee OA
  • Clinically significant joint pain from joints other than the knee
  • Previous intra-articular steroid injection into the study knee within the last 3 months;
  • Previous intra-articular HA injection into the study knee within the last 9 months;
  • Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
  • Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
  • Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
  • Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
  • Change in physical therapy for the knee within the last three months
  • Arthroscopy or other surgical procedure in the study knee within the past 12 months;
  • Any planned arthroscopy or other surgical procedure during the study period;
  • Previous history or presence of active septic arthritis
  • Active skin disease or infection in the area of the injection site;
  • Systemic active inflammatory condition or infection
  • Bleeding diathesis or use of anticoagulants
  • Current uncontrolled diabetes mellitus;
  • Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
  • Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
  • Involvement in other clinical trials
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209364


Locations
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Sponsors and Collaborators
Galderma R&D
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01209364    
Other Study ID Numbers: 35GA0608
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2007
Keywords provided by Galderma R&D:
comparative
randomized
double-blind
non-inferior
knee OA
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents