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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):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01295580
First received: February 11, 2011
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Smith & Nephew, Inc.:

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
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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295580

Locations
China
Beijing University #3 Hospital
Beijing, China
Beijing General Military Hospital
Beijing, China
Beijing Frienship Hospital
Beijing, China
Beijing University People's Hospital
Beijing, China
Zhejiang #2 Hospital
Hangzhou, China
Shanghai #9 People's Hospital
Shanghai, China
Shanghai #6 People's Hospital
Shanghai, China
Sponsors and Collaborators
Smith & Nephew, Inc.
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01295580     History of Changes
Other Study ID Numbers: TG1018DLN
Study First Received: February 11, 2011
Last Updated: February 22, 2012
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
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013