Back to resultsStudy of SI000413 in Knee Osteoarthritis Patients
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SI000413
microcrystalline cellulose
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Males and females, 35-75 years old
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
- Subjects must have been symptomatic for at least 3 months prior to enrollment.
- 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.
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
- Subjects must be able to read, understand and follow the study instructions
- Subjects must agree to informed consent spontaneously.
Exclusion Criteria:
- Subjects who are not using adequate birth control.
- Pregnant or breast-feeding.
- Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
- Secondary OA patients
- Similar OA patients(ex. rheumatic arthritis, bursitis etc)
- Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
- Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
- Anemia or coagulant disorder
- Use of anticoagulants or lithium
- Use of misoprostol or H2-blocker(including anti ulcer medicine)
- Presence or history of gastrointestinal bleeding within the past 1 year.
- Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
- Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
- Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
- Use of glucosamine, chondroitin during the study period.
- Change of concomitant dose/use within 4 weeks.
- Known allergy or hypersensitivity to medicine.
- Subjects received hormone replacement therapy.
- Use of any other investigational drug within 1 month prior to screening.
- Investigators determines that it is not appropriate.
Sites / Locations
- KyungHee University medical centerRecruiting
- Ajou University Medical CenterRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SI000413 400mg
SI000413 600mg
SI000413 800mg
placebo
Arm Description
tablet, SI000413 200mg bid
tablet, SI000413 200mg tid
SI000413 200mg, 2T bid
placebo 2T tid for 8 weeks
Outcomes
Primary Outcome Measures
K-WOMAC
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
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)
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
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
The change from baseline to each day(Visit 4, Visit 6) using laboratory test.
Full Information
NCT ID
NCT01525758
First Posted
January 31, 2012
Last Updated
August 12, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01525758
Brief Title
Study of SI000413 in Knee Osteoarthritis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SI000413 400mg
Arm Type
Experimental
Arm Description
tablet, SI000413 200mg bid
Arm Title
SI000413 600mg
Arm Type
Experimental
Arm Description
tablet, SI000413 200mg tid
Arm Title
SI000413 800mg
Arm Type
Experimental
Arm Description
SI000413 200mg, 2T bid
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo 2T tid for 8 weeks
Intervention Type
Drug
Intervention Name(s)
SI000413
Intervention Description
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
Intervention Type
Drug
Intervention Name(s)
microcrystalline cellulose
Other Intervention Name(s)
SI000413 placebo
Intervention Description
identical number of tablets to active drug groups
Primary Outcome Measure Information:
Title
K-WOMAC
Description
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).
Time Frame
Visit 6(8 week), baseline
Secondary Outcome Measure Information:
Title
knee pain intensity assessment
Description
The change from baseline to each day(4 week and 8 week). Subjects assess knee pain intensity by using 100mm VAS at each time.
Time Frame
baseline, Visit 4(4 week), Visit 6(8 week)
Title
Global assessment(regarding to disease activity)
Description
The change from Visit 4 to Visit 6 using 100mm VAS. Each patient and investigator assess by using 100mm VAS.
Time Frame
Visit 4(4 week), Visit 6(8 week)
Title
K-WOMAC each domain assessment
Description
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
Time Frame
baseline, Visit 6(8 week)
Title
ESR & hs-CRP
Description
The change from baseline to each day(Visit 4, Visit 6) using laboratory test.
Time Frame
baseline, Visit 4(4 week), Visit 6(8 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females, 35-75 years old
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
Subjects must have been symptomatic for at least 3 months prior to enrollment.
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.
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
Subjects must be able to read, understand and follow the study instructions
Subjects must agree to informed consent spontaneously.
Exclusion Criteria:
Subjects who are not using adequate birth control.
Pregnant or breast-feeding.
Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
Secondary OA patients
Similar OA patients(ex. rheumatic arthritis, bursitis etc)
Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
Anemia or coagulant disorder
Use of anticoagulants or lithium
Use of misoprostol or H2-blocker(including anti ulcer medicine)
Presence or history of gastrointestinal bleeding within the past 1 year.
Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
Use of glucosamine, chondroitin during the study period.
Change of concomitant dose/use within 4 weeks.
Known allergy or hypersensitivity to medicine.
Subjects received hormone replacement therapy.
Use of any other investigational drug within 1 month prior to screening.
Investigators determines that it is not appropriate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon-Jae Cho, MD
Email
yjcho@khmc.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Jae Cho, MD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Myung-Chul Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
We-Yeon Won, MD
Organizational Affiliation
Ajou University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
KyungHee University medical center
City
Seoul
State/Province
Hoegi-dong, Dongdaemun-gu
ZIP/Postal Code
130-872
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon-Jae Cho, MD
Facility Name
Ajou University Medical Center
City
Gyeonggi-do
State/Province
Woncheon-dong Yeongtong-gu, Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
We-Yeon Won, MD
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Yongon-dong, Chongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Chul Lee, MD
12. IPD Sharing Statement
Learn more about this trial
Study of SI000413 in Knee Osteoarthritis Patients
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