Study of SI000413 in Knee Osteoarthritis Patients

This study is currently recruiting participants.
Verified August 2013 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01525758
First received: January 31, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: SI000413
Drug: microcrystalline cellulose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eight-week, Multi-centre, Dose-response, Double Blind, Placebo-controlled, Randomized, Parallel-group, PhaseⅡ Trial to Evaluate Efficacy and Safety of SI000413 in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • K-WOMAC [ Time Frame: Visit 6(8 week), baseline ] [ Designated as safety issue: No ]
    The primary endpoint will be the change in the sum of the K-WOMAC OA index at Visit 6(8 weeks) vs. baseline(Visit 2, 0 week).


Secondary Outcome Measures:
  • knee pain intensity assessment [ Time Frame: baseline, Visit 4(4 week), Visit 6(8 week) ] [ Designated as safety issue: No ]
    The change from baseline to each day(4 week and 8 week). Subjects assess knee pain intensity by using 100mm VAS at each time.

  • Global assessment(regarding to disease activity) [ Time Frame: Visit 4(4 week), Visit 6(8 week) ] [ Designated as safety issue: No ]
    The change from Visit 4 to Visit 6 using 100mm VAS. Each patient and investigator assess by using 100mm VAS.

  • K-WOMAC each domain assessment [ Time Frame: baseline, Visit 6(8 week) ] [ Designated as safety issue: No ]

    The change from Visit 6(8 weeks) vs. baseline(Visit 2, 0 week) in the K-WOMAC each domain score.

    * K-WOMAC 3 domains: pain domain, stiffness domain, physical function domain


  • ESR & hs-CRP [ Time Frame: baseline, Visit 4(4 week), Visit 6(8 week) ] [ Designated as safety issue: No ]
    The change from baseline to each day(Visit 4, Visit 6) using laboratory test.


Estimated Enrollment: 152
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SI000413 400mg
tablet, SI000413 200mg bid
Drug: SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
Other Name: SI000413
Experimental: SI000413 600mg
tablet, SI000413 200mg tid
Drug: SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
Other Name: SI000413
Experimental: SI000413 800mg
SI000413 200mg, 2T bid
Drug: SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
Other Name: SI000413
Placebo Comparator: placebo
placebo 2T tid for 8 weeks
Drug: microcrystalline cellulose
identical number of tablets to active drug groups
Other Name: SI000413 placebo

Detailed Description:

This is a dose-response, double blind , placebo-controlled study. All patients are required to have 2 weeks washout period from prior medication. Subjects will discontinue current medications 2 weeks prior to randomization. Among those who meet the inclusion criteria, only subjects recording visual analogue scale(VAS) of higher than 40mm(VAS range from 0mm(no pain) to 100mm(unbearable pain)) are enrolled in this study.

Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, 35-75 years old
  2. Subjects must have a clinical or radiographic diagnosis of primary OA of the knee (diagnosed according to the ACR)

    • The presence of knee pain
    • At least one of the following

      • age older than 50 years
      • morning stiffness lasting less than 30 minutes
      • crepitus with motion
  3. Subjects must have been symptomatic for at least 3 months prior to enrollment.
  4. Subjects must be required to have experienced a pain intensity of at least 40mm on a 100-mm visual analogue scale in the most severely affected joint during the 24 hours prior to randomization.
  5. Adequate liver and kidney function

    • Adequate liver function : SGOT, SGPT must be within 1.5 x normal limit
    • Adequate kidney function : Serum creatinine must be within 1.5 x normal limit
  6. Subjects must be able to read, understand and follow the study instructions
  7. Subjects must agree to informed consent spontaneously.

Exclusion Criteria:

  1. Subjects who are not using adequate birth control.
  2. Pregnant or breast-feeding.
  3. Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
  4. Secondary OA patients
  5. Similar OA patients(ex. rheumatic arthritis, bursitis etc)
  6. Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
  7. Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
  8. Anemia or coagulant disorder
  9. Use of anticoagulants or lithium
  10. Use of misoprostol or H2-blocker(including anti ulcer medicine)
  11. Presence or history of gastrointestinal bleeding within the past 1 year.
  12. Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
  13. Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
  14. Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
  15. Use of glucosamine, chondroitin during the study period.
  16. Change of concomitant dose/use within 4 weeks.
  17. Known allergy or hypersensitivity to medicine.
  18. Subjects received hormone replacement therapy.
  19. Use of any other investigational drug within 1 month prior to screening.
  20. Investigators determines that it is not appropriate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525758

Contacts
Contact: Yoon-Jae Cho, MD yjcho@khmc.or.kr

Locations
Korea, Republic of
KyungHee University medical center Recruiting
Seoul, Hoegi-dong, Dongdaemun-gu, Korea, Republic of, 130-872
Principal Investigator: Yoon-Jae Cho, MD         
Ajou University Medical Center Recruiting
Gyeonggi-do, Woncheon-dong Yeongtong-gu, Suwon, Korea, Republic of, 443-721
Principal Investigator: We-Yeon Won, MD         
Seoul National University Hospital Recruiting
Seoul, Yongon-dong, Chongno-gu, Korea, Republic of, 110-744
Principal Investigator: Myung-Chul Lee, MD         
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Study Chair: Yoon-Jae Cho, MD Kyunghee University Medical Center
Principal Investigator: Myung-Chul Lee, MD Seoul National University Hospital
Principal Investigator: We-Yeon Won, MD Ajou University
  More Information

No publications provided

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01525758     History of Changes
Other Study ID Numbers: SI000413_OA_Ⅱ
Study First Received: January 31, 2012
Last Updated: August 12, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014