Phase 3
Completed N=338
Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
Source: ClinicalTrials.gov NCT01768520 ↗Enrolled (actual)
338
Serious AEs
2.4%
Results posted
Jun 2019
Primary outcomePrimary: the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index) — 51.64; 54.57; 49.94; 30.68 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index) |
51.64; 54.57; 49.94; 30.68; 33.88; 33.80 | — |
| SECONDARY the Change of Numeric Rating Scale |
5.62; 5.54; 5.44; 3.57; 4.09; 4.23 | — |
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
Data sourced from ClinicalTrials.gov (NCT01768520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.