A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

• Conditions: Osteoarthritis

• Registration Number: NCT02064634
• Lead Sponsor: Green Cross Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discontinuation rate due to gastrointestinal adverse effects	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of medication discontinuation	up to 12 weeks	Number of participants discontinued from medication
Discontinuation rate due to adverse events	up to 12 weeks
Rate of medication discontinuation recorded as lack of efficacy	up to 12 weeks	Number of participants discontinued from medication due to lack of efficacy

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Sonpa-gu, Korea, Republic of