A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis

NCT04858659 | Unknown Phase 3

• 1 other identifier: PK101_P301
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change during activity in 100mm Pain VAS

  Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

  baseline through week 8

Secondary Outcomes (5)

• Change during activity in 100mm Pain VAS

  baseline through week 4

• Change at rest in 100mm Pain VAS

  baseline through week 4, 8

• Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score

  baseline through week 4, 8

• Change in PGA

  baseline through week 8

• Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)

  baseline through week 8

Study Arms (2)

PK101 group

EXPERIMENTAL

Drug: PK101; Drug: PK101-002 placebo

PK101-002 group

ACTIVE COMPARATOR

Drug: PK101-002; Drug: PK101 placebo

Interventions

PK101 DRUG

1 tablet at each time, 2 times a day

PK101 group

PK101-002 DRUG

1 tablet at each time, 2 times a day

PK101-002 group

PK101 placebo DRUG

1 tablet at each time, 2 times a day

PK101-002 group

PK101-002 placebo DRUG

1 tablet at each time, 2 times a day

PK101 group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥40 and of age
• Patients who meets the American College Rheumatology (ACR) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis.
• Radiographic evidence of grade 1 \~ 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria at visit 1
• Score of 100mm pain VAS ≤ 80mm at visit 1
• Written consent form voluntarily
• Score of 100mm pain VAS ≥ 40mm at visit 3
• Patients with an individual medication compliance of 70% or more of the IP administered during the Run-in period

You may not qualify if:

• Patients who has a history of hypersensitivity to components of IP, NSAIDs including COX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides
• Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis
• Patients with a condition that can affect the joints
• Patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period
• Patients who have used corticosteroids as follows:
• Inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1
• Oral corticosteroid administration within 1 month prior to visit 1
• Patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1

Sponsors & Collaborators

• PMG Pharm Co., Ltd: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 26, 2021
• Study Start: May 20, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

KR (1)