Clinical trial NCT01525758: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 152
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: K-WOMAC
timeFrame: Visit 6(8 week), baseline
Secondary outcomes:
measure: knee pain intensity assessment
timeFrame: baseline, Visit 4(4 week), Visit 6(8 week)
measure: Global assessment(regarding to disease activity)
timeFrame: Visit 4(4 week), Visit 6(8 week)
measure: K-WOMAC each domain assessment
timeFrame: baseline, Visit 6(8 week)
measure: ESR & hs-CRP
timeFrame: baseline, Visit 4(4 week), Visit 6(8 week)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University medical center
state: Hoegi-dong, Dongdaemun-gu
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
state: Woncheon-dong Yeongtong-gu, Suwon
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Yongon-dong, Chongno-gu
Study officials:
affiliation: Kyunghee University Medical Center
name: Yoon-Jae Cho, MD
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Myung-Chul Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Medical Center
name: We-Yeon Won, MD
role: PRINCIPAL_INVESTIGATOR
References: