OsteoarthritisNCT02064634
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule
An observational study of Osteoarthritis, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 6,700 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2016
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoarthritis being treated with anti-inflammatory analgesic drug at general hospitals and clinics in South Korea
Who may be able to join
- Minimum 20- year-old patients diagnosed with osteoarthritis
- Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)
- Written consent form voluntarity
Who cannot join
- Diagnosed with disease that may affect measurement of efficacy clinically
- Diagnosed with clinically significant phycological disorder, and taking medication
- Participated in a clinical trial within 4 weeks
- Pregnant or lactating woman
- History of malignant disease within the previous 5 years
- Patients who seem not to participate in the study at investigator's discretion
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Sonpa-gu
Seong-Il Bin, M.D., Ph.D, 82-2-3010-3530, sibin@amc.seoul.kr
About this study
Official title: A Multicenter, Comparative, Open Label, Prospective Observational Study on Discontinuation of Medication Due to Gastrointestinal Adverse Effects for the Patients Being Treated for Osteoarthritis With Anti-inflammatory Analgesic Drug
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.
- Conditions
- Osteoarthritis
- Keywords
- Shinbaro Capsule, Celecoxib, Osteoarthritis, GCSB-5, Discontinuation rate, Gastrointestinal adverse event, NSAIDs, OASIS
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shinbaro (only) | Not described | |
| Celecoxib (only) | Not described | |
| Shinbaro + NSAIDs | Not described | |
| Shinbaro + Celecoxib | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation rate due to gastrointestinal adverse effects
Measured: up to 12 weeks
Secondary outcomes (3)
Rate of medication discontinuation recorded as lack of efficacy
Number of participants discontinued from medication due to lack of efficacy
Measured: up to 12 weeks
Rate of medication discontinuation
Number of participants discontinued from medication
Measured: up to 12 weeks
Discontinuation rate due to adverse events
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064634
- Sponsor's protocol ID
- GCSB_OS
- Status last verified
- Mar 2016
- First submitted
- 12 Feb 2014
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Comparative, Open Label, Prospective Observational Study on Discontinuation of Medication Due to Gastrointestinal Adverse Effects for the Patients Being Treated for Osteoarthritis With Anti-inflammatory Analgesic Drug
- ClinicalTrials.gov ID
- NCT02064634
- Acronym / sponsor ID
- GCSB_OS
- Conditions
- Osteoarthritis
- Keywords
- Shinbaro Capsule, Celecoxib, Osteoarthritis, GCSB-5, Discontinuation rate, Gastrointestinal adverse event, NSAIDs, OASIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,700 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Feb 2014 (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 how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shinbaro (only) | – | – |
| Celecoxib (only) | – | – |
| Shinbaro + NSAIDs | – | – |
| Shinbaro + Celecoxib | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthritis being treated with anti-inflammatory analgesic drug at general hospitals and clinics in South Korea
Key inclusion criteria (3 listed)
- Minimum 20- year-old patients diagnosed with osteoarthritis
- Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)
- Written consent form voluntarity
Key exclusion criteria (6 listed)
- Diagnosed with disease that may affect measurement of efficacy clinically
- Diagnosed with clinically significant phycological disorder, and taking medication
- Participated in a clinical trial within 4 weeks
- Pregnant or lactating woman
- History of malignant disease within the previous 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discontinuation rate due to gastrointestinal adverse effects
Time frame: up to 12 weeks
3 secondary outcomes
Rate of medication discontinuation recorded as lack of efficacy
Time frame: up to 12 weeks
Rate of medication discontinuation
Time frame: up to 12 weeks
Discontinuation rate due to adverse events
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Green Cross Corporation at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong-Il Bin, M.D., Ph.D (82-2-3010-3530, sibin@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discontinuation rate due to gastrointestinal adverse effects (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2016.