Clinical trials: Surveillance
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
This study is to investigate the effects of Fiasp®, a mealtime insulin, in patients with diabetes mellitus. The purpose of this study is to collect information about Fiasp®, which is prescribed to the participants by their…
- Trial name
- NCT03987802
- Testing
- Faster-acting insulin aspart
- Where
- 36 sites in India
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
Infections, Rotavirus
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.
- Trial name
- NCT01253967
- Testing
- Collection of stool samples, Health economics questionnaire
- Where
- 8 sites in Romania
- Volunteers
- 1,234 people
- Sponsor
- GlaxoSmithKline
Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
- Trial name
- NCT03214952
- Testing
- Vonoprazan
- Where
- Japan
- Volunteers
- 3,183 people
- Sponsor
- Takeda
Pediatric Crohn's Disease
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea.
- Trial name
- NCT02578238
- Volunteers
- 143 people
- Sponsor
- AbbVie
Prostatic Hyperplasia
A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care setting.
- Trial name
- NCT01003886
- Testing
- Doxazosin mesylate GITS
- Where
- 67 sites in Philippines
- Volunteers
- 989 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Infections, Streptococcal
Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines
The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.
- Trial name
- NCT01046097
- Testing
- Synflorix™
- Where
- 2 sites in Philippines
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Endomicroscopy in Ulcerative Colitis
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy.
- Trial name
- NCT00659867
- Testing
- PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
- Where
- 5 sites in Germany, Italy
- Volunteers
- 182 people
- Sponsor
- PENTAX Europe GmbH
Intracranial Aneurysm
INSPIRE Pipeline™ Shield Post Approval Study
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA)…
- Trial name
- NCT05071963
- Testing
- Treatment of Intracranial Aneurysms
- Where
- 16 sites in United States
- Volunteers
- 246 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Hemophilia B
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown…
- Trial name
- NCT00484185
- Testing
- BeneFIX (coagulation factor IX (recombinant))
- Where
- South Korea
- Volunteers
- 183 people
- Sponsor
- Pfizer
Thromboembolism
PraxbindTM India PMS Program
This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected…
- Trial name
- NCT03359889
- Testing
- PraxbindTM
- Where
- 3 sites in India
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Colorectal Cancer
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
- Trial name
- NCT01694966
- Testing
- Methylene Blue MMX®
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 1,249 people, healthy volunteers welcome
- Sponsor
- Cosmo Technologies Ltd
Renal Cell Carcinoma
Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma
This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell carcinoma.
- Trial name
- NCT04804813
- Testing
- Cabozantinib
- Where
- Japan
- Volunteers
- 388 people
- Sponsor
- Takeda
Chronic Hepatitis C, Hepatitis C
Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus…
- Conditions
- Chronic Hepatitis C, Hepatitis C, HIV Infections
- Trial name
- NCT00736242
- Testing
- PEG-IFN alfa-2b, RBV
- Volunteers
- 232 people
- Sponsor
- Merck Sharp & Dohme LLC
Asthma
Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma
This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.
- Trial name
- NCT00573222
- Testing
- Symbicort
- Where
- 13 sites in Croatia
- Volunteers
- 330 people
- Sponsor
- AstraZeneca
Breast Neoplasm
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).
- Trial name
- NCT03445637
- Where
- South Korea
- Volunteers
- 552 people
- Sponsor
- Pfizer
Outer Retinal Degeneration, Retinitis Pigmentosa
Argus® II Retinal Prosthesis System Post-Market Surveillance Study
This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.
- Trial name
- NCT01490827
- Where
- 10 sites in Germany, Italy
- Volunteers
- 52 people
- Sponsor
- Second Sight Medical Products
Infertility, Reproductive Sterility
Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device
This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use.
- Trial name
- NCT03191890
- Where
- Spain
- Volunteers
- healthy volunteers welcome
- Sponsor
- Anecova SA
Lennox-Gastaut Syndrome
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
This surveillance's objectives are 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Efficacy during long-term administration 4. Factors considered to have effect to safety and effectiveness 5.
- Trial name
- NCT02175173
- Testing
- Rufinamide
- Where
- 2 sites in Japan
- Volunteers
- 707 people
- Sponsor
- Eisai Co., Ltd.
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive…
- Trial name
- NCT06334120
- Testing
- Darolutamide (Nubeqa, BAY1841788)
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Bayer
Aneurysm Thoracic, Dissection of Aorta, Thoracic
TBE Zone 2 PMS in Japan
The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.
- Conditions
- Aneurysm Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07049913
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- W.L.Gore & Associates
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