A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

NCT ID: NCT02064634

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

6700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Shinbaro (only)

No interventions assigned to this group

Celecoxib (only)

No interventions assigned to this group

Shinbaro + NSAIDs

No interventions assigned to this group

Shinbaro + Celecoxib

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, Sonpa-gu, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seong-Il Bin, M.D., Ph.D

Role: CONTACT

82-2-3010-3530

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Seong-Il Bin, M.D., Ph.D

Role: primary

82-2-3010-3530

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCSB_OS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.