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Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Carticept Medical, Inc
ClinicalTrials.gov Identifier:
NCT00642382
First received: March 19, 2008
Last updated: February 13, 2013
Last verified: February 2013

March 19, 2008
February 13, 2013
April 2008
October 2008   (final data collection date for primary outcome measure)
The comparison between the Agilus injection and the saline control injection groups in the proportion of subjects experiencing a reduction in the assessment of pain determined by the AOS subscale for pain. [ Time Frame: At 4, 12 and 26 weeks post 3rd injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642382 on ClinicalTrials.gov Archive Site
Secondary effectiveness parameters that will be evaluated include the following that evaluate pain, function, subject's global assessment, quality of life and an individual subject responder analysis. [ Time Frame: At 4, 12 and 26 weeks post 3rd injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
Randomized, Double Blind,Saline-Controlled, Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Carticept's Agilus Device for the Treatment of Ankle Osteoarthritis

The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.

The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
OSTEOARTHRITIS
  • Device: Agilus
    Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
    Other Name: Hyaluronic Acid
  • Device: Normal saline
    Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
    Other Name: Normal Saline
  • Active Comparator: Active
    Agilus (Hyaluronic Acid)
    Intervention: Device: Agilus
  • Placebo Comparator: Control
    Normal Saline
    Intervention: Device: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
December 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
  • Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
  • Are normally active, without aid of mobility devices(such as crutch, walker or cane)

Exclusion Criteria:

  • Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
  • Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
  • Have received steroid injections in any joint in last 3 months
  • Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00642382
CMI-CP-Ankle-001
No
Carticept Medical, Inc
Carticept Medical, Inc
Not Provided
Principal Investigator: Judith Baumhauer, MD University of Rochester
Carticept Medical, Inc
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP