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Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Durolane
PBS
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Double-blind, Randomized, Intraarticular injection, Hyaluronic acid, Placebo, Knee osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Durolane

PBS

Arm Description

Single intraarticular injection of Durolane

Single intraarticular injection of PBS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2012
Last Updated
August 24, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01753830
Brief Title
Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early due to decision by sponsor
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Double-blind, Randomized, Intraarticular injection, Hyaluronic acid, Placebo, Knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durolane
Arm Type
Experimental
Arm Description
Single intraarticular injection of Durolane
Arm Title
PBS
Arm Type
Placebo Comparator
Arm Description
Single intraarticular injection of PBS
Intervention Type
Device
Intervention Name(s)
Durolane
Intervention Description
4.5 mL
Intervention Type
Device
Intervention Name(s)
PBS
Intervention Description
4.5 mL
Primary Outcome Measure Information:
Title
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.
Time Frame
Up to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nebojsa Skrepnik, MD, PhD
Organizational Affiliation
Tucson Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
City
Anniston
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
El Cajon
State/Province
California
Country
United States
City
Boulder
State/Province
Colorado
Country
United States
City
Danbury
State/Province
Connecticut
Country
United States
City
Trumbull
State/Province
Connecticut
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
South Miami
State/Province
Florida
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Kalamazoo
State/Province
Michigan
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Wyomissing
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

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