A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02064634
• Other study ID #: GCSB_OS
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2014
• Last updated: March 15, 2016
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Green Cross Corporation
• Contact: Seong-Il Bin, M.D., Ph.D
• Phone: 82-2-3010-3530
• Email: sibin[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial Summary

This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6700
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Sonpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation rate due to gastrointestinal adverse effects		up to 12 weeks	Yes
Secondary	Rate of medication discontinuation recorded as lack of efficacy	Number of participants discontinued from medication due to lack of efficacy	up to 12 weeks	No
Secondary	Rate of medication discontinuation	Number of participants discontinued from medication	up to 12 weeks	Yes
Secondary	Discontinuation rate due to adverse events		up to 12 weeks	Yes