Clinical trial NCT01265459: Different Volumes of Durolane in Knee OA
Official title: Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
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 assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.

Detailed description: To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.

Eligibility criteria: Inclusion Criteria:

* Subject (female or male)
* 40-85 years of age
* Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)
* Radiographic evidence of OA in the study knee
* WOMAC pain score of 7-17 in the study knee
* WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)
* Subject normally active
* Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics
* Subject cooperative and able to communicate effectively with the investigators
* Body mass index ≤ 35 kg/m2;
* Signed informed consent obtained

Exclusion Criteria:

* Knee effusion
* Contralateral knee OA
* Clinically significant joint pain from joints other than the knee
* Previous intra-articular steroid injection into the study knee within the last 6 months
* Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months
* Previous allergic type reaction to a HA product
* Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit
* Use of analgesics 48 hours preceding the baseline visit
* Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months
* Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
* Change in physical therapy for the knee within the last three months
* Arthroscopy or other surgical procedure in the study knee within the past 12 months
* Serious injuries to the study knee in the past
* Any planned arthroscopy or other surgical procedure during the study period
* Previous history or presence of active septic arthritis
* Active skin disease or infection in the area of the injection site
* Systemic active inflammatory condition or infection
* Bleeding diathesis or use of anticoagulants
* History of drug or alcohol abuse within 6 months
* Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
* Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception
* Involvement in other clinical trials

Primary outcomes:
measure: Change of Pain Over 26 Weeks (Change From Baseline)
timeFrame: 26 weeks after treatment compared to baseline
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.
timeFrame: From baseline to 26 weeks after treatment
measure: WOMAC Stiffness Score (Change From Baseline)
timeFrame: 26 weeks after treatment compared to baseline
measure: WOMAC Physical Function Score (Change From Baseline)
timeFrame: 26 weeks after treatment compared to baseline
measure: Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)
timeFrame: 26 weeks after treatment compared to baseline
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Torsten Adalberth
city: Stockholm
country: Sweden
facility: Christian Akermark
city: Upplands Vasby
country: Sweden
facility: Johan Isacson
Study officials:
affiliation: Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg
name: Per-Erik Melberg, MD
role: PRINCIPAL_INVESTIGATOR
References: