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

Knee Osteoarthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768520
• Other study ID #: HL_ENTR_302
• Status: Completed
• Phase: Phase 3
• Start date: July 2, 2012
• Est. completion date: May 13, 2015

Study information

• Verified date: June 2019
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: May 13, 2015
• Est. primary completion date: October 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks
morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex evening : 1 tab. of active Entelon 150mg
• Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex evening : 1 tab. of placebo Entelon 150mg
• Placebo
morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex evening : 1 tab. of placebo Entelon 150mg

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Bucheon St. Mary's Hospital	Bucheon	Kyoung-gi Do

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline and 12 weeks