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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Shinbaro Capsule
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Shinbaro, Herbal drug

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyungpook national university hospital
  • BundangCha Hospital
  • Inje University Busan Paik Hospital
  • Chungbuk National University Hospital
  • Chonbul National University Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Hospital
  • Chonnam National University Hwasun Hospital
  • Dongguk University Medical Center
  • Inha University Hospital
  • Samsung Medical Center
  • Asan medical Center
  • Gangnam Severance Hospital
  • Inje University Seoul Paik Hospital
  • KyungHee University Medical Center
  • Seoul National University Hospital
  • Ajou University Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shinbaro

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects with gastrointestinal adverse events

Secondary Outcome Measures

percentage of subjects with perforation, ulcer, bleeding
percentage of subjects who withdrew due to GI AEs
Frequency of AEs
WOMAC change from baseline
KKS (Korean Knee Score) change from baseline
100mm pain VAS on walking

Full Information

First Posted
May 21, 2012
Last Updated
November 11, 2013
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01604239
Brief Title
To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Shinbaro, Herbal drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
761 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shinbaro
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Shinbaro Capsule
Intervention Description
600mg twice a day (b.i.d) oral herbal medicine
Primary Outcome Measure Information:
Title
Percentage of subjects with gastrointestinal adverse events
Time Frame
Baseline through 24 weeks
Secondary Outcome Measure Information:
Title
percentage of subjects with perforation, ulcer, bleeding
Time Frame
baseline throgh week 24
Title
percentage of subjects who withdrew due to GI AEs
Time Frame
baseline through week 24
Title
Frequency of AEs
Time Frame
baseline throgh week 24
Title
WOMAC change from baseline
Time Frame
24 weeks
Title
KKS (Korean Knee Score) change from baseline
Time Frame
24 weeks
Title
100mm pain VAS on walking
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BG Lee
Organizational Affiliation
GC Biopharma Corp
Official's Role
Study Chair
Facility Information:
Facility Name
Kyungpook national university hospital
City
Daegu
State/Province
Kyungpook
Country
Korea, Republic of
Facility Name
BundangCha Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Chonbul National University Hospital
City
Chonju
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Deagu
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
Country
Korea, Republic of
Facility Name
Dongguk University Medical Center
City
Ilsan
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inchun
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
130-710
Country
Korea, Republic of
Facility Name
Asan medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27196293
Citation
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.
Results Reference
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To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis

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