SI-613 Study for Knee Osteoarthritis

Phase 2CompletedNCT03209362

Seikagaku Corporation80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

SI-613COMBINATION_PRODUCT

SI-613 will be repeated intra-articularly administered.

PlaceboCOMBINATION_PRODUCT

Placebo will be repeated intra-articularly administered.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (10)

Tucson Orthopaedic Institute

Tucson, Arizona, United States

MM Medical Center, Inc.

Miami, Florida, United States

Quality Research and Medical Center, LLC

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline over 12 weeks

Secondary Outcomes

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.

Time frame: Baseline, Weeks 12 and 26

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.

Time frame: Baseline, Weeks 12 and 26

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.

Time frame: Baseline, Weeks 12 and 26

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.

Time frame: Baseline, Weeks 12 and 26

Data from ClinicalTrials.gov

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