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SI-613 Study for Knee Osteoarthritis

NCT03209362 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-11-04

Study results available
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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.

Conditions

  • Osteoarthritis, Knee

Interventions

COMBINATION_PRODUCT

SI-613

SI-613 will be repeated intra-articularly administered.

COMBINATION_PRODUCT

Placebo

Placebo will be repeated intra-articularly administered.

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • Seikagaku Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2018-08-17
Completion
2018-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209362 on ClinicalTrials.gov