Clinical trials: Pharmacovigilance
Omeprazole
Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
Introduction. The prevalence of the use of drugs that act on the gastric system has increased in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use, mainly as a prophylactic to prevent reflux…
- Trial name
- NCT02278432
- Volunteers
- 427 people
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
Torsades de Pointe Caused by Drug
A Pharmacovigilance Study of Torsade de Pointes
Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death.
- Trial name
- NCT04293432
- Testing
- Drugs, Generic
- Where
- Pakistan
- Volunteers
- 6,670 people
- Sponsor
- University of Peshawar
Adverse Drug Reaction
Pharmacists' Knowledge and Attitudes About ADRs Reporting and Pharmacovigilance Practice in Egyptian Hospitals
The present study has assessed the knowledge, attitude and practice of ADRs reporting among pharmacists, and the perceived factors that may influence reporting.
- Trial name
- NCT05224804
- Testing
- knwoledge
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Fayoum University
Hemophilia B
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
- Trial name
- NCT00714415
- Testing
- BeneFIX
- Where
- 21 sites in Austria, Germany
- Volunteers
- 80 people
- Sponsor
- Pfizer
Adverse Drug Event
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the…
- Trial name
- IMPACTO (NCT05402254)
- Testing
- Pharmacovigilance Program
- Where
- Spain
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- Natalia Rodriguez Galan
Controlled Drug Dependence
Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the…
- Trial name
- NCT03388567
- Testing
- Staff pharmacy whith intervention
- Where
- Colombia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Universidad de Antioquia
Hematological Malignancy, Atrial Fibrillation
Is Ibrutinib-related Atrial Fibrillation Dose Dependent
Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has recently revolutionized the treatment of various chronic B-cell malignancies and particularly chronic lymphocytic leukemia (CLL).
- Trial name
- NCT06224452
- Testing
- ibrutinib exposure
- Where
- France
- Volunteers
- 18,000 people
- Sponsor
- University Hospital, Caen
Cancer
Pancytopenia Related to PARP Inhibitors (PancytoRIB)
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.
- Trial name
- NCT04774627
- Testing
- PARP inhibitor
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen
Schizophrenia, Diabetes
Medication Reviews in Severe Mental Illness
This study aims to investigate the potential beneficial effects of a medication review by a clinical pharmacologist on patients with coexisting severe mental illness and diabetes.
- Conditions
- Schizophrenia, Diabetes, Metabolic Syndrome, Severe Mental Disorder
- Trial name
- NCT05243160
- Testing
- medication review
- Where
- Denmark
- Volunteers
- 48 people
- Sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
Proton Pump Inhibitor Adverse Reaction, Delirium
Delirium Related to Proton Pump Inhibitors Use
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors…
- Conditions
- Proton Pump Inhibitor Adverse Reaction, Delirium, Hyponatremia
- Trial name
- NCT05815550
- Testing
- PPI
- Where
- France
- Volunteers
- 19,081 people
- Sponsor
- University Hospital, Caen
Tuberculosis
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis.
- Trial name
- NCT04916899
- Testing
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Where
- Mexico
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Juvenile Idiopathic Arthritis
Pharmacovigilance in Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents and/or Methotrexate
BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric rheumatic disease (PRD) and an important cause of short and long-term disability.
- Trial name
- PharmaChild (NCT01399281)
- Where
- Italy
- Volunteers
- 9,000 people
- Sponsor
- Istituto Giannina Gaslini
Advanced Melanoma, Hepatitis B
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C…
- Conditions
- Advanced Melanoma, Hepatitis B, Hepatitis C
- Trial name
- Yervoy RMP (NCT02402699)
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
Cancer
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.
- Trial name
- NCT04774406
- Testing
- olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
- Where
- France
- Volunteers
- 2,336 people
- Sponsor
- University Hospital, Caen
Alcohol Use Disorder
Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder
BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of 792 patients during their first year of…
- Trial name
- BACLOPHONE (NCT02596763)
- Testing
- Baclofen
- Where
- 19 sites in France
- Volunteers
- 239 people
- Sponsor
- University Hospital, Lille
Vaccine Adverse Reaction
Transverse Myelitis Related to SARS-CoV-2 Vaccines
Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.
- Trial name
- NCT05178264
- Testing
- SARS-CoV-2 vaccines
- Where
- France
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Multiple Sclerosis, Malignant Tumor
Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
Even though the therapeutic panel for multiple sclerosis (MS) treatment has improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking.
- Trial name
- PVSEPK (NCT04237337)
- Testing
- Exposure to MS drugs
- Volunteers
- 200,000 people
- Sponsor
- University Hospital, Caen
Malaria
Cohort Event Monitoring in Sub Saharan Africa
This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj.
- Trial name
- CEMISA (NCT02817919)
- Where
- 4 sites in Ghana
- Volunteers
- 1,126 people
- Sponsor
- African Collaborating Centre for Pharmacovigilance
Hunter Syndrome
Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)
The purpose of this non-interventional, observational study which is conducted in Mexico is to evaluate the safety profile of elaprase (idulsurfase) in participants with hunter syndrome (mucopolysaccharydosis II) being treated…
- Trial name
- NCT03582449
- Where
- 6 sites in Mexico
- Volunteers
- 5 people
- Sponsor
- Shire
Cancer, Immune-related Adverse Event
EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database
This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database.
- Conditions
- Cancer, Immune-related Adverse Event, Immune Checkpoint Inhibitor-Related Myocarditis
- Trial name
- EXIT (NCT05934214)
- Testing
- Immune checkpoint inhibitor
- Where
- 2 sites in France
- Volunteers
- 141,630 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere