Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee

NCT01768520 | Completed Phase 3 Results

• 1 other identifier: HL_ENTR_302
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)

  Range of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome. Range of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0\~68) Higher scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.

  baseline and 12 weeks

Secondary Outcomes (1)

• the Change of Numeric Rating Scale

  baseline and 12 weeks

Study Arms (3)

Entelon tab. 150mg

EXPERIMENTAL

Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks

Celebrex cap.

ACTIVE COMPARATOR

Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks DRUG

1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg

Entelon tab. 150mg

Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks DRUG

1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg

Celebrex cap.

Placebo DRUG

1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both gender,35 years ≤ age ≤ 75 years
• patients with a diagnosis of OA(osteoarthritis) of the knee within 3 months prior to study participation, as determined by the American College of Rheumatology clinical and radiographic criteria as follows.
• knee arthralgia
• more than one case among
• years or over
• morning stiffness less than 30 min
• friction sound
• osteophyte in radiography
• Kellgren and Lawrence Scale Grade II\~III
• total sum of K-WOMAC Scale more than 30
• negative results in pregnancy test of urine in screening period
• if women in childbearing age, medically reliable contraception or menopause
• patients who give written consent of agreement to voluntarily participate in the clinical study
• patients who can read and understand written instructions

You may not qualify if:

• patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1
• fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout
• knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis
• anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint
• wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation
• patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation
• severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma
• medical history of malignant tumor
• active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease
• hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose
• continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation
• pregnant or lactating women
• patients who have experience to participate in other clinical trial within 4 weeks prior to study participation
• ALT, AST and Serum Creatinine ≥ 2×UNL
• drug administration after diagnosing as alcoholic or psychical disease

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, Kyoung-gi Do, 420-717, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

whole grape extract; Celecoxib; WW Domain-Containing Oxidoreductase

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; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Trial Unit
• Organization: Hanlim Pharm

yrsong@hanlim.com

82234896297

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 15, 2013
• Study Start: July 2, 2012
• Primary Completion: October 15, 2014
• Study Completion: May 13, 2015
• Last Updated: July 2, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-06

Locations

KR (1)