NCT01604239 is a Phase 4 clinical trial of Shinbaro Capsule in Osteoarthritis, sponsored by Green Cross Corporation.

Who is sponsoring NCT01604239?

NCT01604239 is sponsored by Green Cross Corporation.

What drugs are being tested in NCT01604239?

Interventions in NCT01604239: Shinbaro Capsule.

What condition does NCT01604239 study?

NCT01604239 studies Osteoarthritis.

Is NCT01604239 still recruiting?

NCT01604239 is currently completed. Last updated 11 November 2013.

Last reviewed 2013-11-11 · How we verify

NCT01604239

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis

Completed Phase 4 Last updated 11 November 2013

What this trial tests

Phase 4 trial testing Shinbaro Capsule in Osteoarthritis in 761 participants. Completed in 1 June 2013.

Timeline

1 May 2012

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Green Cross Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	761
Start date	1 May 2012
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	18 locations across South Korea

Drugs / interventions tested

Shinbaro Capsule — full drug profile →

Conditions studied

Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Green Cross Corporation — full company profile →

Who can join

19 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of subjects with gastrointestinal adverse events
Time frame: Baseline through 24 weeks

Sponsor's own description

This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study.
Ha CW, Park YB, Kyung HS, Han CS, et al · · 2016 · cited 7× · PMID 27196293 · DOI 10.1016/j.jep.2016.05.031

Verify or expand the search:

Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

NCT07404891 — Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis · NA · recruiting
NCT07118501 — A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System · recruiting
NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting

Other Green Cross Corporation trials

Trials by the same sponsor.

NCT01624532 — A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 · Phase 2 · completed
NCT04555148 — COVIDIG (COVID-19 Hyper-ImmunoGlobulin) · Phase 2 · completed
NCT04175522 — Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis: · Phase 2 · completed
NCT03947138 — A Study of GC3107(BCG Vaccine) in Healthy Infants · Phase 3 · completed
NCT03492710 — Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency · Phase 3 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01604239 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Green Cross Corporation
Last refreshed: 11 November 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01604239.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing