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: March 17, 2014
Last verified: March 2014
  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: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
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:


Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Change of Pain Over 26 Weeks (Change From Baseline) [ Time Frame: 26 weeks after treatment compared to baseline ] [ Designated as safety issue: No ]

    The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.

    It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.



Secondary Outcome Measures:
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment. [ Time Frame: From baseline to 26 weeks after treatment ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?".

  • WOMAC Stiffness Score (Change From Baseline) [ Time Frame: 26 weeks after treatment compared to baseline ] [ Designated as safety issue: No ]

    The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.

    It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.


  • WOMAC Physical Function Score (Change From Baseline) [ Time Frame: 26 weeks after treatment compared to baseline ] [ Designated as safety issue: No ]

    The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.

    It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.


  • Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline) [ Time Frame: 26 weeks after treatment compared to baseline ] [ 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, Subject global assessment scale, from "very poor=0" to "excellent=10".


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 3ml
Durolane 3 ml is an Intraarticular hyaluronic acid
Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
Durolane is an intraarticular hyaluronic acid preparation
Experimental: Durolane 4.5
Durolane 4.5 is an Intraarticular hyaluronic acid
Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
Durolane is an intraarticular hyaluronic acid preparation
Experimental: Durolane 6 ml
Durolane 6 ml is an Intraarticular hyaluronic acid
Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
Durolane is an 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 3, 2013
Last Updated: March 17, 2014
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
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014