Study Stopped
Study terminated early due to decision by sponsor
Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis
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
1 other identifier
interventional
75
1 country
25
Brief Summary
The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Dec 2012
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
September 30, 2020
CompletedAugust 26, 2022
September 1, 2020
1.2 years
December 12, 2012
September 4, 2020
August 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.
Up to 30 weeks
Study Arms (2)
Durolane
EXPERIMENTALSingle intraarticular injection of Durolane
PBS
PLACEBO COMPARATORSingle intraarticular injection of PBS
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) ≤ 35 kg/m2
- Symptomatic osteoarthritis (OA) of the knee
- K L severity grade 1 or 2
- If bilateral OA, contralateral knee K L severity grade 0 or 1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (25)
Unknown Facility
Anniston, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
El Cajon, California, United States
Unknown Facility
Boulder, Colorado, United States
Unknown Facility
Danbury, Connecticut, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
South Miami, Florida, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Wheaton, Maryland, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Wyomissing, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Q-Med AB
Study Officials
- PRINCIPAL INVESTIGATOR
Nebojsa Skrepnik, MD, PhD
Tucson Orthopaedic Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2012
First Posted
December 20, 2012
Study Start
December 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
August 26, 2022
Results First Posted
September 30, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share