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Different Volumes of Durolane in Knee OA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01265459
First received: December 17, 2010
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  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
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 May 16, 2013