Clinical trial NCT01768520: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 338
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: the Change of Numeric Rating Scale
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St. Mary's Hospital
state: Kyoung-gi Do
Study officials:
References: