Clinical trial NCT01753830: 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
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Double-blind
Randomized
Intraarticular injection
Hyaluronic acid
Placebo
Knee osteoarthritis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
timeFrame: Up to 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: El Cajon
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Lauderdale Lakes
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Wheaton
country: United States
state: Maryland
city: Kalamazoo
country: United States
state: Michigan
city: Springfield
country: United States
state: Missouri
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Tucson Orthopaedic Institute
name: Nebojsa Skrepnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: