Clinical Trial of YYC301 P3 for Treatment of Osteoarthritis of the Knee

a Multicenter, Double-blind, Randomized, Active Drug Control, Parallel Design Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of YYC301 in Patients With Osteoarthritis of the Knee Joint

A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phase 3 Clinical Trial to Evaluate the Efficacy and Safety of YYC301 in Patients with Osteoarthritis of the Knee Joint

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: YYC301-1 & YYC301-2 & YYC301-3; Drug: YYC301 placebo & Celecoxib 200mg

• Study Type: Interventional
• Enrollment (Anticipated): 692
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Soo Min Lee, bachelor; Phone Number: 82-2-6202-7119; Email: smlee@yypharm.co.kr
• Study Contact Backup: Name: Min Ji Kim, bachelor; Phone Number: 82-2-6202-7106; Email: dnminj@yypharm.co.kr

Study Locations

• Korea, Republic of
  • Dongdaemun-gu /Kyung Hee Dae-ro 23
    • Seoul, Dongdaemun-gu /Kyung Hee Dae-ro 23, Korea, Republic of, 02447
      • Recruiting
      • Kyunghee University Medical Center
      • Contact: Kyoung Ho Yoon, Ph.D.; Phone Number: 82-2-958-8374; Email: kyoungho@khmc.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men/Women aged over 20

• Subjects who are diagnosed with one- or both-sided knee osteoarthritis according to the standards of clinical diagnosis from American College of Rheumatology(ACR)have knee osteoarthritis pain and meet over three of the following conditions.

  1. Older than 50
  2. Morning stiffness for less than 30 minutes
  3. Crepitus on active motion
  4. Bony tenderness
  5. Bony enlargement
  6. Not have heat-generating site
• Subjects who are diagnosed with degenerative osteoarthritis and have its pain at least for over 3 months before the screening visit.
• Subjects who are uncontrolled with pain after administration of Celecoxib at least for over 2 weeks before the randomization and have more than 50mm out of 100mm VAS at randomization.
• Subjects who voluntarily agree to participate in this clinical trial in writing.

Exclusion Criteria:

• Subjects with rheumatoid arthritis or inflammatory, infectiousand metabolic arthritis.
• Subjects with ochronosis, hemochromatosis, secondary knee osteoarthritis by systemic disease.
• Subjects who have severe pain such as Sudek's atrophy, Paget's disease and spinal disc herniation.
• Subjects with poly-articular affected by severe pain of knee osteoarthritis.
• Subjects who take psychtrophic medicine and narcotic analgesics for over 3 months that might affect on pain sensory system.
• Subjects who had Tramadol but there was no improvement in pain.

• Subjects who got the follwing treatment and medicine before the screening;

  1. Subjects who had surgery on knee ligaments within a year, cartilage transplant and scarf osteotomy.
  2. Subjects who had arthroscopy within 6 months.
  3. Subjects with intra-articular knee joint steroid injection within 3 months.
  4. Subjects with HA injection in knee joint within 6 months.
  5. Subjects with systemic steroid injection within a month(but inhaled steroids)
  6. Subjects with knee replacement surgery.

• Subjects who hot the following treatment and medicine before the randomization;

  1. Subjects who had Celecoxib, acetaminophen or steroidal/non-steroidal anti-inflammatory drugs except low dose aspirin(before 300mg/day) But, acetaminophen and low dose aspirin (before 300mg/day) are prohibited within 24 hours)
  2. Nutritional supplements, physical therapy and Korean herbal medicine for knee osteoarthritis and it pain within 2 weeks.
• Subjects who have to take anticoagulant drugs such as warfarin and coumarin during this clinical trial.
• Subjects who took MAO inhibitors within 14 days before the screening or needed to take these drugs during this clinical trials.
• Subjects with drug and opioid hypersensitivity and who have history.
• Subjects with sulfanilamide allergy and who have history.
• Subjects with asthmma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction to aspirin or any oher NSAIDs(incluing COX-2 inhibitors)
• Subjects with significant investigations - Hyperkalemia(Exceeded 5.5mmol/L)
• Subjects with severe liver dysfunction (ALT or AST of more than 3.0 times the upper limit of ULN and 1.5 tmines the upper limit of ULN)
• Subjects with severe renal impairment (Serum Creatine > 3x ULN).
• Subjects with active peptic ulcer and gastrointestinal bleeding.
• Severe blood disease (Agranulocytosis, aplastic anemia, hemolytic anemia, Thrombocytopenia, etc.).
• Subjects with Crohn's disease or inflammatory bowel disease such as ulcerative clitis.
• Subjects with congestive heart failure(NYHA 2-4)
• Subjects with severe ischaemic heart disease, peripheral artery disease and/or cerebrovascular disease.
• Subjects with genetic problesa such as galactose intolerance), lapp lactase deficiency or glucose-galactose malabsorption).
• Subjects with acute alcohol intoxification.
• Subjects who are addicted with took central nervous system drugs such as painkillers, sleeping pills, anti-anxiety medications, etc.
• Subjects with severe bronchopulmonary dysplasia.
• Subjects with head injury history of brain structure lesions which may be in danger of mental confusion.
• Subjects with epilepsy who are treated properly.
• Subjects who use Tramadol to cure for narcotic withdrawal.
• Subjects who took other clinical drugs more than once within 30 days before the clinical trial.
• Subjects suspected to be pregnant who don't agree with the clinical method which is permitted medically during clinical trial(Method of hormone contraception, IUD(Intrauterine device) or IUS(Intrauterine system)), tubal ligation, bilateral tubal ligation(condom, Diaphragm, etc).
• Pregnant woman and breastfeeding woman.
• Subjects who can increase risk due to clinical test and administraion of drugs or have severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of thest results.
• Any other ineligible condition at the direction of investigator that would be ineligible to participate the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YYC301-1, YYC301-2, YYC301-3 & Celecoxib placebo; YYC301-1 is a capsule. It is composed of Celecoxib 200mg and Tramadol 37.5mg complex.; YYC301-2 is a capsule. It is composed of Celecoxib 200mg and Tramadol 75mg complex.; YYC301-3 is a capsule. It is composed of Celecoxib 200mg and Tramadol 150mg complex.	Drug: YYC301-1 & YYC301-2 & YYC301-3; YYC301-1: Subjects take the investigational products once a day YYC301-2: Subjects take the investigational products once a day YYC301-3: Subjects take the investigational products once a day; Other Names: YYC301-1: Tramadol 37.5Mg+ Celecoxib 200mg; YYC301-2: Tramadol 75mg+ Celecoxib 200mg; YYC301-3: Tramadol 150mg+ Celecoxib 200mg
Active Comparator: YYC301-1 placebo, YYC301-2 placebo, YYC301-3 placebo & Celecoxib; Concomitant Drugs with Celecoxib 200mg and YYC301-1 placebo one capsule. Concomitant Drugs with Celecoxib 200mg and YYC301-2 placebo one capsule. Concomitant Drugs with Celecoxib 200mg and YYC301-3 placebo one capsule.	Drug: YYC301 placebo & Celecoxib 200mg; comparator medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100mm Pain VAS	Subjects who have severe pain at one-or both sided knee osteoarthritis directly assess the degree of pain (within 24 hours) with a straight line which has 0mm to 100mm. 0 mm means 'doesn't have pain' and 100 mm means 'maximum pain who can imagine'.In order to investigate the degree of subject's pain change from administration of YYC301(Experimental drug).	at 13 weeks after randomization after administration of YYC301(Experimental drug).

Collaborators and Investigators

• Sponsor: Yooyoung Pharmaceutical Co., Ltd.
• Collaborators: CliPSBnC
• Investigators: Principal Investigator: Kyoung Ho Yoon, Ph.D., Kyunghee University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Cyclooxygenase 2 Inhibitors; Celecoxib; Tramadol
• Other Study ID Numbers: YYPCT_YYC301_301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No