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

NCT ID: NCT01768520

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-02
• Study Completion Date: 2015-05-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Entelon tab. 150mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

2. evening : 1 tab. of active Entelon 150mg

Celebrex cap.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

2. evening : 1 tab. of placebo Entelon 150mg

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

2. evening : 1 tab. of placebo Entelon 150mg

Interventions

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

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

2. evening : 1 tab. of active Entelon 150mg

Intervention Type: DRUG

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

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

2. evening : 1 tab. of placebo Entelon 150mg

Intervention Type: DRUG

Placebo

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

2. evening : 1 tab. of placebo Entelon 150mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. both gender,35 years ≤ age ≤ 75 years

2. 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

3. Kellgren and Lawrence Scale Grade II~III

4. total sum of K-WOMAC Scale more than 30

5. negative results in pregnancy test of urine in screening period

6. if women in childbearing age, medically reliable contraception or menopause

7. patients who give written consent of agreement to voluntarily participate in the clinical study

8. patients who can read and understand written instructions

Exclusion Criteria

1. patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1

2. fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout

3. knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis

4. anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint

5. wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation

6. patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation

7. severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma

8. medical history of malignant tumor

9. active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease

10. hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose

11. continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation

12. pregnant or lactating women

13. patients who have experience to participate in other clinical trial within 4 weeks prior to study participation

14. ALT, AST and Serum Creatinine ≥ 2×UNL

15. drug administration after diagnosing as alcoholic or psychical disease

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Bucheon-si, Kyoung-gi Do, South Korea

Countries

South Korea

Other Identifiers

HL_ENTR_302

Identifier Type: -

Identifier Source: org_study_id