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SI-613 Study for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SI-613
Placebo
Sponsored by
Seikagaku Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee, Osteoarthritis, Intra-articular injection

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provides their written informed consent.
  • Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
  • Is willing to switch to using acetaminophen as a rescue medication

Exclusion Criteria:

  • Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
  • Secondary OA
  • Is a female subject who is pregnant or lactating.
  • Is currently hospitalized or has a planned hospitalization during the life of the study.

Sites / Locations

  • Tucson Orthopaedic Institute
  • MM Medical Center, Inc.
  • Quality Research and Medical Center, LLC
  • Heartland Research Associates, LLC
  • Central Kentucky Research Associates
  • Sundance Clinical Research, LLC
  • Rochester Clinical Research
  • Upstate Clinical Research Associates, LLC
  • New Horizons Clinical Research
  • Altoona Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SI-613

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.

Secondary Outcome Measures

Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Change From Baseline in WOMAC Total Score at Weeks 12 and 26
WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.

Full Information

First Posted
July 4, 2017
Last Updated
November 1, 2021
Sponsor
Seikagaku Corporation
Collaborators
Chiltern International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03209362
Brief Title
SI-613 Study for Knee Osteoarthritis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
Collaborators
Chiltern International Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee, Osteoarthritis, Intra-articular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SI-613
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Combination Product
Intervention Name(s)
SI-613
Intervention Description
SI-613 will be repeated intra-articularly administered.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Placebo will be repeated intra-articularly administered.
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
Description
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
Time Frame
Baseline over 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
Description
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Time Frame
Baseline, Weeks 12 and 26
Title
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
Description
Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Time Frame
Baseline, Weeks 12 and 26
Title
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
Description
Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Time Frame
Baseline, Weeks 12 and 26
Title
Change From Baseline in WOMAC Total Score at Weeks 12 and 26
Description
WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Time Frame
Baseline, Weeks 12 and 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provides their written informed consent. Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria Is willing to switch to using acetaminophen as a rescue medication Exclusion Criteria: Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening. Secondary OA Is a female subject who is pregnant or lactating. Is currently hospitalized or has a planned hospitalization during the life of the study.
Facility Information:
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
MM Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Quality Research and Medical Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

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SI-613 Study for Knee Osteoarthritis

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