Text Size

Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

This study is currently recruiting participants.
Verified May 2013 by Q-Med AB
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01753830
First received: December 12, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of the study is to determine whether a single intra-articular injection of Durolane is superior to a single injection of PBS for the relief of joint pain in patients with osteoarthritis of the knee.


Condition Intervention Phase
Knee Osteoarthritis
 Device: Durolane
Device: PBS
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Outcome Measures in Rheumatology Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) Response [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]
  • WOMAC Physical Function score [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]
  • Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life questionnaire [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]
  • Physical Global Evaluation [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]
  • Patient Global Evaluation [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: December 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durolane
Single intraarticular injection of Durolane
 Device: Durolane
Placebo Comparator: PBS
Single intraarticular injection of PBS
 Device: PBS

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) ≤ 35 kg/m2
  • Symptomatic OA of the knee
  • K L severity grade 1 or 2
  • If bilateral OA, contralateral knee K L severity grade 0 or 1

Exclusion Criteria:

  • Has clinically apparent tense effusion of the index knee
  • Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
  • Has any painful orthopedic disorders of the back or hip
  • Has a joint disorder other than osteoarthritis in the index knee
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753830

Contacts
Contact: Melanie Bammert +1 919 724 6947 melanie.bammert@aptivsolutions.com

  Show 25 Study Locations
Sponsors and Collaborators
Q-Med AB
Investigators
Study Director: Sara Olofsson, PhD Q-Med AB
Principal Investigator: Nebojsa Skrepnik, MD, PhD Tucson Orthopaedic Institute
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01753830     History of Changes
Other Study ID Numbers: 35GA1203
Study First Received: December 12, 2012
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Q-Med AB:
Double-blind
Randomized
Intraarticular injection
 Hyaluronic acid
Placebo
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013