Osteoarthritis
Conditions
Keywords
Shinbaro Capsule, Celecoxib, Osteoarthritis, GCSB-5, Discontinuation rate, Gastrointestinal adverse event, NSAIDs, OASIS
Brief summary
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.
Interventions
None listed
Sponsors
Green Cross Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discontinuation rate due to gastrointestinal adverse effects | up to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of medication discontinuation recorded as lack of efficacy | up to 12 weeks | Number of participants discontinued from medication due to lack of efficacy |
| Rate of medication discontinuation | up to 12 weeks | Number of participants discontinued from medication |
| Discontinuation rate due to adverse events | up to 12 weeks | — |
Countries
South Korea
Contacts
Primary ContactSeong-Il Bin, M.D., Ph.D
Outcome results
None listed