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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01604239
First received: May 21, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Drug: Shinbaro Capsule
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Percentage of subjects with gastrointestinal adverse events [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • percentage of subjects with perforation, ulcer, bleeding [ Time Frame: baseline throgh week 24 ] [ Designated as safety issue: Yes ]
  • percentage of subjects who withdrew due to GI AEs [ Time Frame: baseline through week 24 ] [ Designated as safety issue: Yes ]
  • Frequency of AEs [ Time Frame: baseline throgh week 24 ] [ Designated as safety issue: Yes ]
  • WOMAC change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • KKS (Korean Knee Score) change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 100mm pain VAS on walking [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 761
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shinbaro Drug: Shinbaro Capsule
600mg twice a day (b.i.d) oral herbal medicine

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604239

Locations
Korea, Republic of
Kyungpook national university hospital
Daegu, Kyungpook, Korea, Republic of
BundangCha Hospital
Bundang, Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of
Chonbul National University Hospital
Chonju, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Yeungnam University Hospital
Deagu, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Korea, Republic of
Dongguk University Medical Center
Ilsan, Korea, Republic of
Inha University Hospital
Inchun, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Inje University Seoul Paik Hospital
Seoul, Korea, Republic of
Asan medical Center
Seoul, Korea, Republic of
KyungHee University Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 130-710
Seoul National University Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
Study Chair: BG Lee Green Cross Corp
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01604239     History of Changes
Other Study ID Numbers: GCSB_P4
Study First Received: May 21, 2012
Last Updated: November 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Green Cross Corporation:
Osteoarthritis
Shinbaro
Herbal drug

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014