OsteoarthritisPhase 4NCT01604239
To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
A Phase 4 study testing Shinbaro Capsule in people with Osteoarthritis, run by Green Cross Corporation at 18 sites in South Korea.
Trial summary
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Shinbaro Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 761 participants
- Where
- 18 sitesSouth Korea
- Study dates
- May 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
BundangCha Hospital
Bundang
Inje University Busan Paik Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
Kyungpook national university hospital
Daegu, Kyungpook
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Hospital
Deagu
Chonnam National University Hwasun Hospital
Hwasun
Dongguk University Medical Center
Ilsan
Inha University Hospital
Inchun
Chonbul National University Hospital
Jeonju
Samsung Medical Center
Seoul, 130-710
Asan medical Center
Seoul
Gangnam Severance Hospital
Seoul
Inje University Seoul Paik Hospital
Seoul
KyungHee University Medical Center
Seoul
Seoul National University Hospital
Seoul
Ajou University Hospital
Suwon
Ulsan University Hospital
Ulsan
About this study
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
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Shinbaro Capsule
- Keywords
- Osteoarthritis, Shinbaro, Herbal drug
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shinbaro CapsuleDrug
600mg twice a day (b.i.d) oral herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| Shinbaro | Experimental | Not described Receives: Drug: Shinbaro Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with gastrointestinal adverse events
Measured: Baseline through 24 weeks
Secondary outcomes (6)
percentage of subjects with perforation, ulcer, bleeding
Measured: baseline throgh week 24
percentage of subjects who withdrew due to GI AEs
Measured: baseline through week 24
Frequency of AEs
Measured: baseline throgh week 24
WOMAC change from baseline
Measured: 24 weeks
KKS (Korean Knee Score) change from baseline
Measured: 24 weeks
100mm pain VAS on walking
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BG Lee, Study chair, GC Biopharma Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604239
- Sponsor's protocol ID
- GCSB_P4
- Status last verified
- Nov 2013
- First submitted
- 21 May 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27196293
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01604239
- Acronym / sponsor ID
- GCSB_P4
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Shinbaro, Herbal drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shinbaro | Experimental | Drug: Shinbaro Capsule |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shinbaro Capsule600mg twice a day (b.i.d) oral herbal medicine | Drug | Shinbaro |
Primary outcome
Percentage of subjects with gastrointestinal adverse events
Time frame: Baseline through 24 weeks
6 secondary outcomes
percentage of subjects with perforation, ulcer, bleeding
Time frame: baseline throgh week 24
percentage of subjects who withdrew due to GI AEs
Time frame: baseline through week 24
Frequency of AEs
Time frame: baseline throgh week 24
WOMAC change from baseline
Time frame: 24 weeks
KKS (Korean Knee Score) change from baseline
Time frame: 24 weeks
100mm pain VAS on walking
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 27196293Ha 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.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BG Lee study chair
GC Biopharma Corp
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shinbaro Capsule in people with Osteoarthritis, run by Green Cross Corporation at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with gastrointestinal adverse events (time frame: Baseline through 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.