NCT02064634

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

February 12, 2014

Last Update Submit

March 15, 2016

Conditions

Osteoarthritis

Keywords

Shinbaro CapsuleCelecoxibOsteoarthritisGCSB-5Discontinuation rateGastrointestinal adverse eventNSAIDsOASIS

Outcome Measures

Primary Outcomes (1)

  • Discontinuation rate due to gastrointestinal adverse effects

    up to 12 weeks

Secondary Outcomes (3)

  • Rate of medication discontinuation recorded as lack of efficacy

    up to 12 weeks

  • Rate of medication discontinuation

    up to 12 weeks

  • Discontinuation rate due to adverse events

    up to 12 weeks

Study Arms (4)

Shinbaro (only)

Celecoxib (only)

Shinbaro + NSAIDs

Shinbaro + Celecoxib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Sonpa-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

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

CONTACT

82-2-3010-3530sibin@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

KR(1)