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Completed

NCT Number: NCT03209362

SI-613 Study for Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tucson Orthopaedic Institute, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SI-613

Combination Product

SI-613 will be repeated intra-articularly administered.

Placebo

Combination Product

Placebo will be repeated intra-articularly administered.

Primary outcomes

  1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks

    Time frame: Baseline 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 outcomes

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Collaborators

  • Chiltern International Inc.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2017
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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