Trial record 1 of 1 for:    NCT01295580
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Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT01295580
First received: February 11, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine the comparative safety and efficacy of knee intra-articular injection of hyaluronic acid obtained from two different sources in the treatment of knee osteoarthritis.


Condition Intervention Phase
Knee Osteoarthritis
Device: Hyaluronic acid, stabilized
Device: Hyaluronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Bioventus LLC:

Primary Outcome Measures:
  • WOMAC(Western Ontario and McMaster Osteoarthritis Index) Pain [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC(Western Ontario and McMaster Osteoarthritis Index) subscale for pain, stiffness, and physical function [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hyaluronic acid, stabilized Device: Hyaluronic acid, stabilized
Hyaluronic acid
Active Comparator: Hyaluronic acid Device: Hyaluronic acid
Hyaluronic acid

Detailed Description:

This is a multicenter, randomized, double blind, parallel-controlled clinical trial using a non-inferiority comparison to evaluate the efficacy and safety of an intra-articular injection of Durolane® vs Artz® in the treatment of knee osteoarthritis. Subjects will be randomized 1:1 to receive either Durolane or Artz. All subjects will be followed up for 26 weeks from the initial treatment.The screening period is expected to be up to 2 weeks in duration before the baseline visit. Each subject will provide a written informed consent and undergo a qualifying screening. Assessment at screening will include postero-anterior view of standing weight-bearing semi-flexed radiographs of the study knee. The OA changes of the study knee will be graded 0,1,2,3 or 4 according to the Kellgren-Lawrence radiographic scoring criteria. Radiographic assessment will be made by an assigned and well trained investigator at each study center. The study knee and contralateral knee will use the Likert WOMAC 5-point scoring for pain assessment.

Physical examination of the knees and vital signs will be performed (this examination will be repeated at end).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject (female or male) 40-80 years of age, inclusive
  • Documented diagnosis of mild to moderate osteoarthritis of the study knee that fulfil the ACR(American College of Rheumatology) criteria
  • Radiographic evidence of osteoarthritis in the study knee (Kellgren Lawrence radiographic score is 2 or 3)

Exclusion Criteria:

  • Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella
  • Kellgren-Lawrence radiographic score 0, 1 or 4 in the study knee
  • Symptomatic osteoarthritis of the contralateral knee or of either hip that is not responsive to acetaminophen/paracetamol and/or requires any protocol prohibited therapies
  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: NCT01295580

Locations
China
Beijing Frienship Hospital
Beijing, China
Beijing General Military Hospital
Beijing, China
Beijing University #3 Hospital
Beijing, China
Beijing University People's Hospital
Beijing, China
Zhejiang #2 Hospital
Hangzhou, China
Shanghai #6 People's Hospital
Shanghai, China
Shanghai #9 People's Hospital
Shanghai, China
Sponsors and Collaborators
Bioventus LLC
Investigators
Principal Investigator: Jianhao Lin, MD People Hospital of Beijing University No. 11 South Ave., Xizhimen, Beijing
  More Information

No publications provided

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT01295580     History of Changes
Other Study ID Numbers: TG1018DLN
Study First Received: February 11, 2011
Last Updated: July 22, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on October 20, 2014