Study of SI000413 in Knee Osteoarthritis Patients

NCT01525758 | Unknown Phase 2

• 1 other identifier: SI000413_OA_Ⅱ
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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).

  Visit 6(8 week), baseline

Secondary Outcomes (4)

• knee pain intensity assessment

  baseline, Visit 4(4 week), Visit 6(8 week)

• Global assessment(regarding to disease activity)

  Visit 4(4 week), Visit 6(8 week)

• K-WOMAC each domain assessment

  baseline, Visit 6(8 week)

• ESR & hs-CRP

  baseline, Visit 4(4 week), Visit 6(8 week)

Study Arms (4)

SI000413 400mg

EXPERIMENTAL

tablet, SI000413 200mg bid

Drug: SI000413

SI000413 600mg

EXPERIMENTAL

tablet, SI000413 200mg tid

Drug: SI000413

SI000413 800mg

EXPERIMENTAL

SI000413 200mg, 2T bid

Drug: SI000413

placebo

PLACEBO COMPARATOR

placebo 2T tid for 8 weeks

Drug: microcrystalline cellulose

Interventions

SI000413 DRUG

1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks

SI000413 400mg; SI000413 600mg; SI000413 800mg

microcrystalline cellulose DRUG

identical number of tablets to active drug groups

Also known as: SI000413 placebo

placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead

Study Sites (3)

KyungHee University medical center

Seoul, Hoegi-dong, Dongdaemun-gu, 130-872, South Korea

RECRUITING

Ajou University Medical Center

Gyeonggi-do, Woncheon-dong Yeongtong-gu, Suwon, 443-721, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Yongon-dong, Chongno-gu, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

SI 000413; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yoon-Jae Cho, MD

  Kyunghee University Medical Center

  STUDY CHAIR

• Myung-Chul Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• We-Yeon Won, MD

  Ajou University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon-Jae Cho, MD

CONTACT

yjcho@khmc.or.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

KR (3)