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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

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

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

Placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
1. knee arthralgia
2. more than one case among
  - 50 years or over
    - morning stiffness less than 30 min
      - friction sound
3. 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

Exclusion Criteria:

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
patients whom the investigators judge as improper to participate in this clinical trial

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Entelon tab. 150mg

Celebrex cap.

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the Change of Numeric Rating Scale

Numeric Rating Scale is 10 point scale(0~10 score). 0 score: no pain, 10 score: worst possible pain If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.

Full Information

NCT ID

NCT01768520

First Posted

January 14, 2013

Last Updated

June 23, 2019

Sponsor

Hanlim Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01768520

Brief Title

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

Official Title

For 12 Weeks, the Multi-center, Randomized, Double-blinded, Clinical Study to Evaluate the Efficacy and Safety of Entelon Tab. 150mg Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee (Phase III)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

July 2, 2012 (Actual)

Primary Completion Date

October 15, 2014 (Actual)

Study Completion Date

May 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanlim Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

338 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Entelon tab. 150mg

Arm Type

Experimental

Arm Title

Celebrex cap.

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

baseline and 12 weeks

Secondary Outcome Measure Information:

Title

the Change of Numeric Rating Scale

Description

Numeric Rating Scale is 10 point scale(0~10 score). 0 score: no pain, 10 score: worst possible pain If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.

Time Frame

baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 50 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 Exclusion Criteria: 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 patients whom the investigators judge as improper to participate in this clinical trial

Facility Information:

Facility Name

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

City

Bucheon

State/Province

Kyoung-gi Do

ZIP/Postal Code

420-717

Country

Korea, Republic of

12. IPD Sharing Statement

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

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