A Prospective Observational Study on Discontinuation of M... | NCT02064634

Studies
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

NCT02064634

Sponsor

Green Cross Corporation

Status

Unknown status

Last Update Posted

Mar 17, 2016Estimated

Enrollment

6,700Estimated

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 12, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2016

Last Update Posted Date

Mar 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,700Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Rate of medication discontinuation recorded as lack of efficacy	Number of participants discontinued from medication due to lack of efficacy	up to 12 weeks
Rate of medication discontinuation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seong-Il Bin, M.D., Ph.D	Contact	82-2-3010-3530		sibin@amc.seoul.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul	Sonpa-gu		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Shinbaro (only)
Celecoxib (only)
Shinbaro + NSAIDs
Shinbaro + Celecoxib