Clinical trials: PMS
PMS
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.
- Trial name
- NCT00523705
- Testing
- escitalopram
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Pennsylvania
Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma
Alvopem® (Pemetrexed) Safety Assessment
The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma.
- Trial name
- NCT04843007
- Testing
- Pemetrexed
- Volunteers
- 199 people
- Sponsor
- NanoAlvand
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
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
Diabetes Mellitus, Type 2
PMS of Trazenta on the Long-term Use as Add-on Therapy
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
- Trial name
- NCT01904383
- Testing
- Trazenta
- Where
- Japan
- Volunteers
- 4,057 people
- Sponsor
- Boehringer Ingelheim
Product Surveillance, Postmarketing
Post Marketing Surveillance Study For Sayana®
Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain
- Trial name
- SAYANA (NCT02104557)
- Testing
- Non intervention
- Where
- 19 sites in South Korea
- Volunteers
- 362 people
- Sponsor
- Pfizer
Carcinoma, Non-Small-Cell Lung
Long-term Observation PMS for Afatinib
In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination.
- Trial name
- NCT02131259
- Testing
- Afatinib dimaleate
- Where
- 432 sites in Japan
- Volunteers
- 1,605 people
- Sponsor
- Boehringer Ingelheim
Human Papillomavirus Infection Leading to Cervical Cancer
A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.
The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of…
- Trial name
- NCT00730847
- Testing
- Cervarix
- Where
- 2 sites in Philippines
- Volunteers
- 743 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
Japanese Pradaxa PMS, Long Term
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
- Trial name
- NCT03175198
- Testing
- Prazaxa® Capsules
- Where
- Japan
- Volunteers
- 5,660 people
- Sponsor
- Boehringer Ingelheim
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Phelan-McDermid Syndrome, Epilepsy
AMO-01 to Treat Adolescents and Adults With Phelan-McDermid Syndrome (PMS) and Co-morbid Epilepsy
The purpose of this study is to investigate the safety, tolerability and efficacy of a single 6-hour intravenous infusion of AMO-01 to treat adolescents and adults with PMS and co-morbid epilepsy.
- Trial name
- NCT03493607
- Testing
- AMO-01
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Alexander Kolevzon
Cervical Intraepithelial Neoplasia
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18.
- Trial name
- NCT03438006
- Testing
- Safety data collection (following routine vaccination)
- Where
- 7 sites in China
- Volunteers
- 3,016 people, healthy volunteers welcome
- 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
Diphtheria, Tetanus
Post Marketing Surveillance for ADACEL™ in South Korea
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01137435
- Testing
- ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
- Where
- 2 sites in South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hemophilia B
RIXUBIS PMS India (RIXUBIS PMS)
The purpose of this study is to characterize the safety and describe the effectiveness of RIXUBIS in routine clinical practice.
- Trial name
- NCT03565237
- Testing
- RIXUBIS: On-Demand, RIXUBIS: Prophylaxis
- Where
- India
- Volunteers
- 25 people
- Sponsor
- Baxalta now part of Shire
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
Heart Failure
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.
- Trial name
- NCT05262764
- Testing
- JARDIANCE®
- Where
- Japan
- Volunteers
- 1,200 people
- Sponsor
- Boehringer Ingelheim
Benign Prostatic Hyperplasia, Prostatic Hyperplasia
AVODART(Dutasteride) Post-marketing Surveillance(PMS)
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
- Trial name
- AVO PMS (NCT01299571)
- Testing
- Dutasteride
- Where
- South Korea
- Volunteers
- 3,977 people
- Sponsor
- GlaxoSmithKline
Bipolar Disorder, Schizophrenia
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy)…
- Trial name
- NCT01053429
- Testing
- ziprasidone
- Volunteers
- 3,391 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Infections, Rotavirus, Rotavirus Vaccines
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the…
- Trial name
- NCT00353366
- Testing
- Rotarix, Data collection
- Where
- 18 sites in Philippines
- Volunteers
- 1,439 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline