Clinical trials: Prescribing
Cow's Milk Protein Allergy
Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is…
- Trial name
- DELISA (NCT06273371)
- Testing
- Damira 2000 Infant formula
- Where
- 8 sites in Spain
- Volunteers
- 61 people
- Sponsor
- Lactalis
Infections, Streptococcal
Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.
- Trial name
- NCT01248988
- Testing
- Synflorix™ Data collection
- Where
- South Korea
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Impetigo
EU PV for Retapamulin-Prescribing
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the European Union (EU), retapamulin is approved for the treatment of impetigo and…
- Trial name
- NCT01153828
- Testing
- Retapamulin, Co-prescription of retapamulin and topical mupirocin, Co-prescription of retapamulin and topical fusidic acid
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Rhinitis, Allergic, Perennial and Seasonal
Regulatory AVAMYS Nasal Spray PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
- Trial name
- NCT01001130
- Testing
- fluticasone furoate group
- Where
- South Korea
- Volunteers
- 3,244 people
- Sponsor
- GlaxoSmithKline
Lung Cancer, Small Cell
Regulatory Hycamtin(Oral) PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information
- Trial name
- Hycamtin PMS (NCT01037023)
- Testing
- Topotecan
- Where
- 2 sites in South Korea
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Influenza
Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
- Trial name
- NCT00750360
- Testing
- FluarixTM
- Volunteers
- 883 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Idiopathic Parkinson Disease
Transdermal Rotigotine User Surveillance Study
This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.
- Trial name
- TRUST (NCT00599339)
- Where
- 211 sites in Czechia, Denmark and 8 more
- Volunteers
- 2,195 people
- Sponsor
- UCB Pharma
Infections, Meningococcal
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY).
- Trial name
- NCT00290329
- Testing
- Mencevax ACWY
- Where
- 8 sites in Philippines
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertension, Heart Failure
Regulatory Nebilet PMS
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information
- Trial name
- Nebilet PMS (NCT01077661)
- Testing
- Nebivolol
- Where
- South Korea
- Volunteers
- 743 people
- Sponsor
- GlaxoSmithKline
Seizures
Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France.
- Trial name
- OPERA (NCT05772429)
- Testing
- Epidiolex
- Where
- 29 sites in France
- Volunteers
- 158 people
- Sponsor
- Jazz Pharmaceuticals
Infections, Papillomavirus
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs…
- Trial name
- NCT01101542
- Testing
- Cervarix., Data collection
- Where
- 2 sites in South Korea
- Volunteers
- 3,091 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Osteoarthritis, Rheumatoid Arthritis
Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)
This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout
- Trial name
- NCT01685424
- Testing
- Etoricoxib
- Volunteers
- 79,189 people
- Sponsor
- Organon and Co
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
Contraceptives, Oral, Combined
Observational Trial With Leios/Alesse
A prospective, observational study (Anwendungsbeobachtung [AWB]) of the prescribing and administration practices of German gynecologists with Leios® Dragées.
- Trial name
- NCT00481650
- Testing
- Leios/Alesse
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Solid Tumours, Bone Metastasis
Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer.
- Trial name
- NCT01998607
- Testing
- Physician Survey
- Volunteers
- 420 people
- Sponsor
- Amgen
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
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
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
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™
This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Delivery Systems
- Trial name
- NCT01500486
- Testing
- NordiFlex PenMate™
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 84 people
- Sponsor
- Novo Nordisk A/S