Clinical trials: Korean
Respiratory Syncytial Virus Infection
Surveillance of Synagis in Korean Pediatric Patients
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT01537198
- Volunteers
- 618 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Rhinitis, Allergic, Perennial and Seasonal
Regulatory AVAMYS Nasal Spray PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
- Trial name
- NCT01001130
- Testing
- fluticasone furoate group
- Where
- South Korea
- Volunteers
- 3,244 people
- Sponsor
- GlaxoSmithKline
Hepatitis A Vaccine
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine
The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
- Trial name
- VITHA-C (NCT03654664)
- Testing
- Inactivated hepatitis A vaccine, Havrix Inj
- Where
- 10 sites in South Korea
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Healthy Male
Food Effect Study of IDX-1197 in Healthy Subjects
Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers
- Trial name
- NCT05202912
- Testing
- IDX-1197(After a meal), IDX-1197(fasting)
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Idience Co., Ltd.
Aspergillosis, Mucormycosis
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food…
- Trial name
- NCT04744454
- Testing
- Isauvuconazole group
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Pfizer
Herpes Zoster, Shingles
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study.
- Trial name
- NCT01556451
- Testing
- Zoster Vaccine Live
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Epilepsy
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
- Trial name
- NCT01140867
- Testing
- zonisamide
- Where
- 10 sites in South Korea
- Volunteers
- 121 people
- Sponsor
- Eisai Korea Inc.
Colorectal Neoplasms
A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551.
- Trial name
- NCT01082315
- Testing
- Erbitux (Cetuximab)
- Where
- South Korea
- Volunteers
- 730 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Pain
An Observational Study to Investigate Clinical Usefulness of OROS Hydromorphone in Korean Cancer Patients
This study aims to collect clinical information and to examine the usefulness and safety of ORal Osmotic System Hydromorphone in Korean cancer patients.
- Trial name
- NCT01273454
- Testing
- OROS Hydromorphone
- Volunteers
- 648 people
- Sponsor
- Janssen Korea, Ltd., Korea
Advanced Renal Cell Carcinoma
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.
- Trial name
- NCT02156895
- Testing
- Axitinib
- Where
- South Korea
- Volunteers
- 111 people
- Sponsor
- Pfizer
Tuberculosis, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Healthy Volunteers
Safety and Tolerability of NTX-101 in Korean Healthy Volunteers
A double-blinded, placebo controlled, multiple dose, randomized, single site, phase 1 clinical trial to evaluate safety, tolerability, and pharmacokinetics of NTX-101 topical eye drop in Korean healthy volunteers
- Trial name
- NCT05041543
- Testing
- NTX-101
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pinotbio, Inc.
Multiple Sclerosis, Relapsing-remitting
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting multiple sclerosis (MS) under routine…
- Trial name
- NCT05366036
- Testing
- No Intervention
- Where
- 20 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- Eisai Korea Inc.
Mental Health Services, Personality
Validation of Schema Scale of Mental Health Service
Digital Mental Health Service, MINDLiNG, has developed Schema Scale that identifies individual's personality based on schema theory. The goal of this study is to determine the reliability and validity of the Schema Scale.
- Trial name
- NCT05952063
- Testing
- Digital Psychological Test: Schema Scale
- Where
- South Korea
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- 40FY
Head and Neck Cancer
Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck in Korea
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551.
- Trial name
- NCT01075828
- Testing
- Cetuximab
- Where
- South Korea
- Volunteers
- 221 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy
This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, which is required by the Ministry…
- Trial name
- NCT04801329
- Testing
- Vyndamax (tafamidis 61mg)
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Pfizer
Seizures
Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369 at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial epilepsy patients who have poor seizure…
- Trial name
- NCT00697762
- Testing
- RWJ-333369
- Volunteers
- 56 people
- Sponsor
- SK Life Science, Inc.
Cardiovascular Diseases, Blood Pressure Disorders
Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults
The objectives of this clinical trial are to 1) determine the effect of the TP compared to placebo on blood flow and platelet aggregation, 2) to determine the effect of the TP on cardiovascular health compared to a placebo and 3)…
- Conditions
- Cardiovascular Diseases, Blood Pressure Disorders, Vasodilation, Platelet Aggregation
- Trial name
- NCT06236243
- Testing
- Korean Red Ginseng Extract Powder 120 mg/tablet, Korean Red Ginseng Extract Powder 500 mg/tablet
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Korea Ginseng Corporation
Leukemia, Myelomonocytic, Chronic, Leukemia-Lymphoma
Korean Post-marketing Surveillance for Sprycel®
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory…
- Trial name
- NCT01464047
- Where
- South Korea
- Volunteers
- 670 people
- Sponsor
- Bristol-Myers Squibb
Colorectal Cancer
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy.
- Trial name
- KRG (NCT02039635)
- Testing
- Korean Red Ginseng
- Where
- South Korea
- Volunteers
- 438 people
- Sponsor
- Korea Ginseng Corporation