To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis

A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis

This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Shinbaro Capsule

• Study Type: Interventional
• Enrollment (Actual): 761
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang, Korea, Republic of
    • BUNDANGCHA HOSPITAL
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chonju, Korea, Republic of
    • Chonbul National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Deagu, Korea, Republic of
    • Yeungnam University Hospital
  • Hwasun, Korea, Republic of
    • Chonnam National University Hwasun Hospital
  • Ilsan, Korea, Republic of
    • Dongguk University Medical Center
  • Inchun, Korea, Republic of
    • Inha University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 130-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Inje University Seoul Paik Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Kyungpook
    • Daegu, Kyungpook, Korea, Republic of
      • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Minimum 19 years old
• Kellgren stage I ~ III by ACR criteria
• Stable osteoarthritis during 3 months
• Be able to perform WOMAC and KKS
• Written consent form voluntarily

Exclusion Criteria:

• Disease of orthopaedic surgical that could affect to evaluate the efficacy
• Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
• Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
• Medical history of hypersensitivity reaction against Herbal drug
• Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
• Occurrence of OA caused by the injury
• Diagnosed with psychical disorder, and taking medication
• Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
• Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
• Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
• Positive in fecal occult blood test
• Gastrointestinal tract surgery except appendectomy
• Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
• Participation in another clinical trials within 4 weeks
• Not consent about using effectual contraception method during trial
• Pregnant or lactating woman
• Medical history of malignant tumor within 5 years
• Investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shinbaro	Drug: Shinbaro Capsule; 600mg twice a day (b.i.d) oral herbal medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with gastrointestinal adverse events	Baseline through 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
percentage of subjects with perforation, ulcer, bleeding	baseline throgh week 24
percentage of subjects who withdrew due to GI AEs	baseline through week 24
Frequency of AEs	baseline throgh week 24
WOMAC change from baseline	24 weeks
KKS (Korean Knee Score) change from baseline	24 weeks
100mm pain VAS on walking	24 weeks

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Study Chair: BG Lee, GC Biopharma Corp

Publications and helpful links

General Publications

• Ha CW, Park YB, Kyung HS, Han CS, Bae KC, Lim HC, Park SE, Lee MC, Won YY, Lee DC, Cho SD, Kim CW, Kim JG, Kang JS, Lee JH, Choi ES, Seon JK, Lee WS, Bin SI. Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study. J Ethnopharmacol. 2016 Aug 2;189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 11, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Osteoarthritis; Shinbaro; Herbal drug
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: GCSB_P4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No