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A Trial of SB-061 in Osteoarthritis of the Knee (MODIFY-OA)

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ClinicalTrials.gov Identifier: NCT02802709
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Nordic Bioscience Clinical Development
Information provided by (Responsible Party):
Symic OA Co.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: SB-061 Other: Placebo Phase 1 Phase 2

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 2 intra-articular injections of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee
Study Start Date : May 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: SB-061
SB-061
Device: SB-061
delivered via intra-articular injection

Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Pain [ Time Frame: Baseline, 3 months ]
    Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 3 months post treatment will be compared between treatment and control groups.

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through 3 months ]
    A summary of Treatment-Emergent Adverse Events will be reported


Secondary Outcome Measures :
  1. Pain [ Time Frame: Baseline, 3 months ]
    Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 3 months post treatment will be compared between treatment and control groups.

  2. Physical function [ Time Frame: Baseline, 3 months ]
    Change in Patient Global Assessement scores from baseline to 3 months post treatment will be compared between treatment and control groups.

  3. Pain [ Time Frame: Baseline, 3 months ]
    Change in Numeric Rating Scale (NRS) of pain from baseline to 3 months post treatment will be compared between treatment and control groups.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802709


Locations
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Estonia
CCBR
Tallinn, Estonia, 10128
Medita Kliinik
Tartu, Estonia, 50107
Sponsors and Collaborators
Symic OA Co.
Nordic Bioscience Clinical Development
Investigators
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Study Director: Nathan Bachtell, MD Symic OA Co.
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Responsible Party: Symic OA Co.
ClinicalTrials.gov Identifier: NCT02802709    
Other Study ID Numbers: TP-1621
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Symic OA Co.:
knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases