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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hanlim Pharm. Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01768520
First received: January 14, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768520

Locations
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    solan42@naver.com   
Contact: Su Yon Kim, CRM    82 2 3489 6167    cutty0314@hanlim.com   
Principal Investigator: Jun Ki Min, Professor         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
  More Information

No publications provided

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01768520     History of Changes
Other Study ID Numbers: HL_ENTR_302
Study First Received: January 14, 2013
Last Updated: January 14, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014