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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Hanlim Pharm. Co., Ltd..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd. Identifier:
First received: January 14, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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.

Condition Intervention Phase
Knee Osteoarthritis
Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks
Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • the change of total sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index) [ Time Frame: 12 weeks from first drug administration ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: for the entire study period(12 weeks) ]

Estimated Enrollment: 336
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Entelon tab. 150mg Drug: 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
Active Comparator: Celebrex cap. 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
Placebo Comparator: Placebo Drug: Placebo
  1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex
  2. evening : 1 tab. of placebo Entelon 150mg


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01768520

Korea, Republic of
The Catholic University of Korea, Bucheon St. Mary's Hospital Recruiting
Bucheon, Kyoung-gi do, Korea, Republic of, 420-717
Contact: Ji Sun Park, CRC    82 32 340 7236   
Contact: Su Yon Kim, CRM    82 2 3489 6167   
Principal Investigator: Jun Ki Min, Professor         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
  More Information

Responsible Party: Hanlim Pharm. Co., Ltd. Identifier: NCT01768520     History of Changes
Other Study ID Numbers: HL_ENTR_302
Study First Received: January 14, 2013
Last Updated: January 14, 2013

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017