Clinical trial NCT04858659: A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-designed, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PK101 Compared With PK101-002 in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: PMG Pharm Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 354
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change during activity in 100mm Pain VAS
timeFrame: baseline through week 8
Secondary outcomes:
measure: Change during activity in 100mm Pain VAS
timeFrame: baseline through week 4
measure: Change at rest in 100mm Pain VAS
timeFrame: baseline through week 4, 8
measure: Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score
timeFrame: baseline through week 4, 8
measure: Change in PGA
timeFrame: baseline through week 8
measure: Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)
timeFrame: baseline through week 8
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
Study officials:
References: