Clinical trials: PMS
Immunisation Against Streptococcus Pneumoniae
Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
- Trial name
- NCT01803425
- Testing
- Synflorix™ data collection
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Cancer, Biliary Tract Cancer
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
- Trial name
- Imfinzi PMS (NCT04068168)
- Where
- 24 sites in South Korea
- Volunteers
- 712 people
- Sponsor
- AstraZeneca
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
- Trial name
- NCT03471728
- Testing
- linaclotide
- Where
- 47 sites in Japan
- Volunteers
- 2,475 people
- Sponsor
- Astellas Pharma Inc
Premenstrual Syndrome
Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome
With the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (OLP) intervention in premenstrual syndrome (PMS) and to contribute to a broader understanding of how OLPs work.
- Trial name
- NCT06206460
- Testing
- Online Assessment
- Where
- Switzerland
- Volunteers
- 66 people
- Sponsor
- University Hospital, Basel, Switzerland
Gaucher Disease
Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India
The main aim of this study is to measure the safety and to find out the effects of VPRIV in participants with Gaucher disease using both retrospective and prospective data when used in the post-marketing setting and to collect…
- Trial name
- NCT04429984
- Where
- 2 sites in India
- Volunteers
- 21 people
- Sponsor
- 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
Premenstrual Syndrome
Effect of Connective Tissue Massage on Premenstrual Syndrome
This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.
- Trial name
- NCT06621680
- Testing
- Multivitamins, Connective tissue massage
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Cairo University
PMS, Hot Flashes
A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia.
- Trial name
- RDC (NCT02100540)
- Testing
- II RDC 0.3mg capsule, III RDC 0.6mg capsule
- Where
- Taiwan
- Volunteers
- 58 people
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
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
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
Poliomyelitis
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).
- Trial name
- NCT00514033
- Testing
- Poliomyelitis vaccine (inactivated) -PoliorixTM
- Where
- South Korea
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Osteoporosis
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
This is an open label, multi-centre, non-interventional post-marketing surveillance.
- Trial name
- BONPMS (NCT01381393)
- Testing
- Ibandronate
- Where
- South Korea
- Volunteers
- 659 people
- Sponsor
- GlaxoSmithKline
Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing…
- Trial name
- NCT05665374
- Where
- 15 sites in Japan
- Volunteers
- 67 people
- Sponsor
- AstraZeneca
Hepatitis A
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
- Trial name
- NCT01838070
- Where
- South Korea
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Kidney Disease
Forxiga CKD Japan Post-Marketing Surveillance (PMS)
To capture safety when Forxige is administrated to CKD patients in the real world setting
- Trial name
- NCT05306210
- Where
- 46 sites in Japan
- Volunteers
- 1,029 people
- Sponsor
- AstraZeneca
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
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.
Fabry Disease
China Post-marketing Surveillance (PMS) Study of Fabrazyme®
This is a 54-week Phase 4, open label, single arm study to evaluate the safety and the efficacy of Fabrazyme (agalsidase beta) as enzyme replacement therapy (ERT) in Chinese participants with Fabry Disease.
- Trial name
- NCT05054387
- Testing
- Agalsidase beta
- Where
- 6 sites in China
- Volunteers
- 22 people
- Sponsor
- Genzyme, a Sanofi Company
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
Parkinson Disease
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
- Trial name
- NCT02248168
- Testing
- Pramipexole
- Volunteers
- 1,449 people
- Sponsor
- Boehringer Ingelheim