SI-613 Study for Knee Osteoarthritis

Seikagaku

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Combination Product: SI-613; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03209362

613 /1121

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

SI-613

Experimental group

Treatment:

Combination Product: SI-613

Placebo

Placebo Comparator group

Treatment:

Combination Product: Placebo