Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01753830
First received: December 12, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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:


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 ]

Enrollment: 75
Study Start Date: December 2012
Primary Completion Date: February 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
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: NCT01753830

  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: August 4, 2014
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 September 30, 2014