Durolane Versus Methylprednisolone in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01209364
First received: September 20, 2010
Last updated: November 6, 2012
Last verified: August 2007
  Purpose

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 Intervention Phase
Knee Osteoarthritis
Device: Durolane is a device, methylprednisolone in a drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Pain level and responder rate [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC stiffness score [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ] [ Designated as safety issue: No ]
    Will be assessed at each clinic visit

  • WOMAC physical function [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ] [ Designated as safety issue: No ]
    Will be assessed at each clinic visit

  • Functional assessment [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ] [ Designated as safety issue: No ]
    Will be assessed at each clinic visit

  • Safety assessment (Adverse Events) [ Time Frame: 26 weeks blinded phase + 26 weeks OLE ] [ Designated as safety issue: No ]
    Will be assessed at each clinic visit using standard questions


Enrollment: 442
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209364

Locations
Canada, Alberta
Alberta Bone & Joint Health Institute
Calgary, Alberta, Canada, T2P 3C5
Canada, Newfoundland and Labrador
Nexus Clinical Research
St John´s, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Nova Scotia
Orthopaedic & Sport Medicine Institute of Nova Scotia
Halifax, Nova Scotia, Canada, B3H 4M2
Dr. Wilson
Lunenburg, Nova Scotia, Canada, B0J2C0
Canada, Ontario
QEII Health Sciences Centre-New Halifax Infirmary
Halifax, Ontario, Canada, B3H 3A7
Charlton Medical Centre
Hamilton, Ontario, Canada, L8N 1Y2
MAC Research Inc.
Hamilton, Ontario, Canada, L8N 2B6
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Credit Valley Rheumatology
Mississauga, Ontario, Canada, L5M 2V8
The Arthritis Program Research Group
Newmarket, Ontario, Canada, L3Y 3R7
Dr. Dobson
Peterborough, Ontario, Canada, K9J 6X2
Sport C.A.R.E. Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre de Rhumatologie St-Louis
Saint-Foy, Quebec, Canada, G1W4R4
Canada, Saskatchewan
Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, Canada, S7K 0H6
Sweden
Läkargruppen Kristinelund
Göteborg, Sweden, 411 37
Ortopediska huset
Johanneshov, Sweden, 121 77
Läkarhuset Ellenbogen
Malmö, Sweden, 211 36
Ortopediska huset
Stockholm, Sweden, 11360
United Kingdom
Kings College Hospital - Department of Rheumatology
London, United Kingdom, SE5 9RS
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
Newcastle, United Kingdom, NE1 4LP
Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
Oswestry, United Kingdom, SY10 7AG
Southampton General Hospital - MRC Epidemiology Resource Center
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Q-Med AB
  More Information

No publications provided by Q-Med AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01209364     History of Changes
Other Study ID Numbers: 35GA0608
Study First Received: September 20, 2010
Last Updated: November 6, 2012
Health Authority: Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by Q-Med AB:
comparative
randomized
double-blind
non-inferior
knee OA

Additional relevant MeSH terms:
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
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014