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

• Sponsor: SK Chemicals Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05930080
• Collaborator: (none)
• Enrollment: 278
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 13.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: SKCPT; Drug: Celebrex	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis
• Actual Study Start Date: Jan 28, 2021
• Actual Primary Completion Date: May 19, 2022
• Actual Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SKCPT group	Drug: SKCPT; the randomly assigned subjects took the study drug for 12 weeks
Active Comparator: Celebrex group	Drug: Celebrex; the randomly assigned subjects took the study drug for 12 weeks

Outcome Measures

Primary Outcome Measures

1. K-WOMAC Pain Subscale [84 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• SK Chemicals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SK Chemicals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05930080
• Other Study ID Numbers: SKCPT_001
• First Posted: Jul 5, 2023
• Last Update Posted: Jul 6, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Celecoxib

Study Results

No Results Posted as of Jul 6, 2023