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Trial record 2 of 2 for:    Symic OA

A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee (MODIFY2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231280
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Nordic Bioscience A/S
Information provided by (Responsible Party):
Symic OA Co.

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date April 19, 2018
Actual Study Start Date  ICMJE August 14, 2017
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Pain [ Time Frame: Baseline, 4 weeks ]
    Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through 4 weeks ]
    A summary of Treatment-Emergent Adverse Events will be reported
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Pain [ Time Frame: Baseline, 4 weeks ]
    Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.
  • Physical function [ Time Frame: Baseline, 4 weeks ]
    Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
  • Pain [ Time Frame: Baseline, 4 weeks ]
    Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
Official Title  ICMJE A Placebo-controlled, Double-blind, Randomized Trial of a Single Intra-articular Delivery of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee
Brief Summary This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.
Detailed Description The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Device: SB-061
    delivered via intra-articular injection
  • Other: Placebo
    Placebo delivered via intra-articular injection
Study Arms  ICMJE
  • Experimental: SB-061
    SB-061
    Intervention: Device: SB-061
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 27, 2018
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Femorotibial osteoarthritis of the knee
  • Radiological OA Kellgren-Lawrence grade 2 or 3
  • WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9

Exclusion Criteria:

  • Hypersensitivity to medications or to intra-articular injections
  • Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
  • High dose systemic corticosteroid treatment of longer (>14 days) duration w/in 6 months of study
  • Major surgery or arthroscopy of the target knee within year prior to study
  • Planned surgery in the target knee within the next 3 months
  • Concomitant inflammatory disease affecting either knee
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03231280
Other Study ID Numbers  ICMJE TP-1803
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Symic OA Co.
Study Sponsor  ICMJE Symic OA Co.
Collaborators  ICMJE Nordic Bioscience A/S
Investigators  ICMJE
Study Director: Nathan Bachtell, MD Symic OA Co.
PRS Account Symic OA Co.
Verification Date April 2018

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