Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial

NCT05930080 | Completed Phase 3

• 1 other identifier: SKCPT_001
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• K-WOMAC Pain Subscale

  The average changes in the K-WOMAC(Western Ontario and McMasters Universitis) Pain Subscale (range: 0-100 mm, higher scores mean a worse outcome)

  84 days

Study Arms (2)

SKCPT group

EXPERIMENTAL

Drug: SKCPT

Celebrex group

ACTIVE COMPARATOR

Drug: Celebrex

Interventions

SKCPT DRUG

the randomly assigned subjects took the study drug for 12 weeks

SKCPT group

Celebrex DRUG

the randomly assigned subjects took the study drug for 12 weeks

Celebrex group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females aged 20 to 75 years
• Kellgren-Lawrence (KL) grade 1 to 3
• Individuals who voluntarily decide to participate in the study and provide written informed consent form
• Individuals who can understand and follow instructions and can participate in the study during the entire study period

You may not qualify if:

• Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator
• Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint
• Individuals who have undergone knee joint arthroplasty
• Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 5, 2023
• Study Start: January 28, 2021
• Primary Completion: May 19, 2022
• Study Completion: September 30, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)