Trial record 3 of 196 for:    PBS

Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

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


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

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
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Please refer to this study by its identifier: NCT01753830

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

Responsible Party: Q-Med AB 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:
Intraarticular injection
Hyaluronic acid
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 26, 2016