Clinical trials: Surveillance
Growth Disorders
National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin
The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin…
- Trial name
- NCT00097539
- Testing
- Somatrem, Somatropin
- Volunteers
- 65,205 people
- Sponsor
- Genentech, Inc.
Reflux Esophagitis
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.
- Trial name
- NCT03214081
- Testing
- Vonoprazan
- Where
- Japan
- Volunteers
- 1,237 people
- Sponsor
- Takeda
Prostate Cancer
Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active…
- Trial name
- proSPECT-AS (NCT02615067)
- Testing
- 99mTc-MIP-1404 Injection, Whole-Body Planar and pelvic SPECT/CT scan
- Where
- 45 sites in United States, Canada
- Volunteers
- 531 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Osteoarthritis, Avascular Necrosis
Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study
The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when used in primary hip arthroplasty.
- Conditions
- Osteoarthritis, Avascular Necrosis, Inflammatory Arthritis, Post-traumatic Arthritis
- Trial name
- NCT03343171
- Where
- 6 sites in Finland, Italy and 1 more
- Volunteers
- 203 people
- Sponsor
- Zimmer Biomet
Alopecia
AVODART® Alopecia Post-marketing Surveillance (PMS)
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
- Trial name
- AVODART®PMS (NCT01004809)
- Testing
- Dutasteride
- Where
- South Korea
- Volunteers
- 712 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
- Trial name
- NCT02850978
- Testing
- Spiolto
- Where
- Japan
- Volunteers
- 1,335 people
- Sponsor
- Boehringer Ingelheim
End Stage Kidney Disease
The Vascutek Rapidax™ II Post Market Surveillance Registry
Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.
- Trial name
- NCT01977508
- Testing
- ePTFE vascular access grafts
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Vascutek Ltd.
Non-small Cell Lung Cancer
Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy
This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January…
- Trial name
- NCT03017885
- Where
- 11 sites in India
- Volunteers
- 28 people
- Sponsor
- Boehringer Ingelheim
Paroxysmal Nocturnal Hemoglobinuria, C3 Glomerulopathy
A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
This is a post-marketing surveillance study conducted as part of the Risk Management Plan (RMP) for South Korea, to evaluate the safety and effectiveness of iptacopan in real-world clinical settings for the treatment of either…
- Trial name
- NCT07416162
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
It's a prospective, non-interventional, observational Post-marketing Surveillance..
- Trial name
- NCT04432688
- Testing
- Lurasidone HCl
- Where
- 7 sites in China
- Volunteers
- 3,192 people
- Sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
Osteoporosis
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice…
- Trial name
- NCT01793142
- Testing
- Viviant
- Where
- 60 sites in South Korea
- Volunteers
- 3,430 people
- Sponsor
- Pfizer
Diphtheria-Tetanus-acellular Pertussis Vaccines
Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
- Trial name
- NCT01929291
- Testing
- Boostrix, Safety data collection
- Where
- South Korea
- Volunteers
- 682 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alzheimer's Desease
Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.
- Trial name
- NCT02162251
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 3,482 people
- Sponsor
- Eisai Co., Ltd.
Rheumatoid Arthritis, Osteoarthritis
A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00208429
- Testing
- Pinnacle Acetabular System
- Sponsor
- DePuy International
Aspergillus Infection, Febrile Neutropenia
Ampholipad Real-World Data in Taiwan
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.
- Conditions
- Aspergillus Infection, Febrile Neutropenia, Candida Infection, Fungal Infection
- Trial name
- NCT03641131
- Where
- 6 sites in Taiwan
- Volunteers
- 102 people
- Sponsor
- Taiwan Liposome Company
Osteoarthritis, Traumatic Arthritis
The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy
A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in…
- Trial name
- NCT02539069
- Testing
- Chondron Implantation
- Where
- South Korea
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Hepatitis C
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan.
- Trial name
- NCT02591277
- Testing
- Harvoni
- Where
- 125 sites in Japan
- Volunteers
- 3,294 people
- Sponsor
- Gilead Sciences
Rheumatoid Arthritis, Psoriatic Arthritis
A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
The purpose of this study is to assess the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT01692457
- Testing
- No intervention
- Sponsor
- Janssen Pharmaceutica
Rheumatoid Arthritis
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s…
- Trial name
- NCT00195403
- Testing
- Etanercept
- Where
- 4 sites in South Korea
- Volunteers
- 1,014 people
- Sponsor
- Pfizer
Tourette's Disorder
ABF Tourette's Disorder Post Marketing Surveillance Study
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
- Trial name
- NCT01795105
- Where
- 4 sites in South Korea
- Volunteers
- 692 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
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