Different Volumes of Durolane in Knee OA - Full Text View

Purpose

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.

Condition	Intervention	Phase
Knee Osteoarthritis	Device: Durolane1, Durolane 2, Durolane 3 at different volumes	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Q-Med AB:

Primary Outcome Measures:

Reduction of pain over 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
The study aims to compare the reduction of pain for different volumes of study product over 26 weeks

Secondary Outcome Measures:

Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability will be assessed at each clinic visit. Standard questions will be used.
WOMAC stiffness score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Will be assessed at each clinic visit
WOMAC physical function score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Will be assessed at each clinic visit
Subject´s overall assessment of the status of the study knee. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale from "very poor" to "excellent".

Enrollment:	68
Study Start Date:	January 2011
Study Completion Date:	November 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Durolane 1 Intraarticular hyaluronic acid	Device: Durolane1, Durolane 2, Durolane 3 at different volumes Durolane is a intraarticular hyaluronic acid preparation
Experimental: Durolane 2 Intraarticular hyaluronic acid	Device: Durolane1, Durolane 2, Durolane 3 at different volumes Durolane is a intraarticular hyaluronic acid preparation
Experimental: Durolane 3 Intraarticular hyaluronic acid	Device: Durolane1, Durolane 2, Durolane 3 at different volumes Durolane is a intraarticular hyaluronic acid preparation

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

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265459

Locations

Sweden
Torsten Adalberth
Malmo, Sweden, 211 36
Christian Akermark
Stockholm, Sweden, 111 35
Johan Isacson
Upplands Vasby, Sweden, 194 89

Sponsors and Collaborators

Q-Med AB

Investigators

Principal Investigator:

Per-Erik Melberg, MD

Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg

More Information

No publications provided

Responsible Party:	Q-Med AB
ClinicalTrials.gov Identifier:	NCT01265459 History of Changes
Other Study ID Numbers:	35GA1001
Study First Received:	December 17, 2010
Last Updated:	November 21, 2011
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 18, 2012