Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01753830
• Other study ID #: 35GA1203
• Status: Terminated
• Phase: N/A
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2020
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Durolane
4.5 mL
• PBS
4.5 mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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