Clinical Trial of YYC301 for Treatment of Osteoarthritis of the Knee

NCT03850587 | Completed Phase 2 DMC

• 1 other identifier: YYPCT_YYC301_P2
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 10

Brief Summary

A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phaseII Study to Investigate the Efficacy and Safety of YYC301 in Subject With Knee Osteoarthritis

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• 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 1,4,8,12 weeks after randomization after administration of YYC301(Experimental drug).

• KOOS(Knee Injury and Osteoarthritis Outcome Score)

  KOOS survey is consisted of total 42 questions at 5 groups. 7 questions about symptoms, 9 questions about pain, 17 questions about Function in daily,5 questions about function in sport and recreation(sport/Rec), 4 questions about the knee related quality of life(QoL). Subjects who are participated in this clinical trial, they directly assess these survey with 5 point Likert scale(0\~4, 0 means 'nothing' and 4 means 'most severe') and KOOS results are converted to WOMAC score.

  at 4,8,12 weeks after randomization after administration of YYC301(Experimental drug).

• Patient Global Assessment(PGA)

  Subjects who have been admistrated YYC301 have to directly perform the patient global assessment with 5 point Likert Scale. It has 0 to 5 scales. 0 means 'very poor' and 5 means' very good' In order to investigate the Patient Global point assessment at specific weeks.

  at 4,8,12 weeks after randomization after administration of YYC301(Experimental drug).

• Total dosage and dosage rate of rescue treatment.

  Subjects who administration of YYC301(Experimental drug) are investigated total dosage and dosage rate of rescue treatment.

  at screening time(visit 1; 2 weeks before next visit 2), randomization(visit 2), 4, 8 weeks after randomization.

Study Arms (4)

YYC301-1 & Celocoxib placebo

EXPERIMENTAL

YYC301-1 one capsule and Concomitant Drug Celocoxib placebo. \*YYC301-1 is a capsule. It is composed of Celocoxib 200mg and Tramadol 37.5mg complex).

Drug: Tramadol 37.5Mg+ Celecoxib 200mg

YYC301-2 & Celocoxib placebo

EXPERIMENTAL

YYC301-2 one capsule and Concomitant Drug Celocoxib placebo. \*YYC301-2 is a capsule. It is composed of Celocoxib 200mg and Tramadol 75mg complex)

Drug: Tramadol 75mg+ Celecoxib 200mg

YYC301-3 & Celocoxib placebo

EXPERIMENTAL

YYC301-3 one capsule and Concomitant Drug Celocoxib placebo. \*YYC301-3 is a capsule. It is composed of Celocoxib 200mg and Tramadol 150mg complex)

Drug: Tramadol 150mg+ Celecoxib 200mg

YYC301 placebo & Celecoxib

ACTIVE COMPARATOR

Concomitant Drugs with Celecoxib 200mg and YYC301 one capsule.

Drug: Celecoxib 200mg

Interventions

Celecoxib 200mg DRUG

comparator medication

YYC301 placebo & Celecoxib

Tramadol 37.5Mg+ Celecoxib 200mg DRUG

experimental medication

Also known as: yyc301-1

YYC301-1 & Celocoxib placebo

Tramadol 75mg+ Celecoxib 200mg DRUG

experimental medication

Also known as: yyc301-2

YYC301-2 & Celocoxib placebo

Tramadol 150mg+ Celecoxib 200mg DRUG

experimental medication

Also known as: yyc301-3

YYC301-3 & Celocoxib placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Older than 50
• Morning stiffness for less than 30 minutes
• Crepitus on active motion
• Bony tenderness
• Bony enlargement
• 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 40mm out of 100mm VAS at randomization.
• Subjects who voluntarily agree to participate in this clinical trial in writing.

You may not qualify if:

• 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;
• Subjects who had surgery on knee ligaments within a year, cartilage transplant and scarf osteotomy.
• Subjects who had arthroscopy within 6 months.
• Subjects with intra-articular knee joint steroid injection within 3 months.
• Subjects with HA injection in knee joint within 2 months.
• Subjects with systemic steroid injection within a month(but inhaled steroids)
• Subjects with knee replacement surgery.
• Subjects who hot the following treatment and medicine before the randomization;
• 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)

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead
• CliPS Co., Ltd: collaborator

Study Sites (10)

Dong-A University Hospital.

Busan, South Korea

Location

Bundang Seoul University Hospital

Seoul, South Korea

Location

Gachon University Gil Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

KyungHee University Medical Center

Seoul, South Korea

Location

Soonchungyand University Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital.

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Celecoxib; Tramadol

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; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The purpose of this study is to investigate the efficacy and safety after administration of YYC301(Experimental) or Celecoxib(Comparator) in subjects with knee osteoarthritis in a state of uncontrolled pain who took Celecoxib(Cox-2 inhibitor).

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: August 30, 2018
• Primary Completion: May 12, 2020
• Study Completion: September 7, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

KR (10)