NCT03209362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 16, 2021

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

July 4, 2017

Results QC Date

August 16, 2021

Last Update Submit

November 1, 2021

Conditions

Osteoarthritis, Knee

Keywords

KneeOsteoarthritisIntra-articular injection

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline over 12 weeks

Secondary Outcomes (4)

  • Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26

    Baseline, Weeks 12 and 26

  • Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26

    Baseline, Weeks 12 and 26

  • Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26

    Baseline, Weeks 12 and 26

  • Change From Baseline in WOMAC Total Score at Weeks 12 and 26

    Baseline, Weeks 12 and 26

Study Arms (2)

SI-613

EXPERIMENTAL
Combination Product: SI-613

Placebo

PLACEBO COMPARATOR
Combination Product: Placebo

Interventions

SI-613COMBINATION_PRODUCT

SI-613 will be repeated intra-articularly administered.

SI-613
PlaceboCOMBINATION_PRODUCT

Placebo will be repeated intra-articularly administered.

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

MM Medical Center, Inc.

Miami, Florida, 33185, United States

Location

Quality Research and Medical Center, LLC

Miami, Florida, 33186, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

diclofenac etalhyaluronate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Clinical Development Dept.
Organization
Seikagaku Corporation
taku.hosaka@seikagaku.co.jp
(81)3-5220-8948

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

October 19, 2017

Primary Completion

August 17, 2018

Study Completion

November 13, 2018

Last Updated

November 4, 2021

Results First Posted

September 16, 2021

Record last verified: 2021-11

Locations

US(10)