A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

March 15, 2016 updated by: Green Cross Corporation

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

6700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Sonpa-gu
      • Seoul, Sonpa-gu, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with osteoarthritis being treated with anti-inflammatory analgesic drug at general hospitals and clinics in South Korea

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Shinbaro (only)
Celecoxib (only)
Shinbaro + NSAIDs
Shinbaro + Celecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Discontinuation rate due to gastrointestinal adverse effects
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of medication discontinuation recorded as lack of efficacy
Time Frame: up to 12 weeks
Number of participants discontinued from medication due to lack of efficacy
up to 12 weeks
Rate of medication discontinuation
Time Frame: up to 12 weeks
Number of participants discontinued from medication
up to 12 weeks
Discontinuation rate due to adverse events
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCSB_OS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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