Clinical trials: Prescribing
Analgesia
ULTIVA Post Marketing Surveillance
This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to…
- Trial name
- NCT01299584
- Testing
- Remifentanil
- Volunteers
- 775 people
- Sponsor
- GlaxoSmithKline
Epilepsy
Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine…
- Trial name
- NCT01210690
- Where
- 27 sites in France, Germany and 5 more
- Volunteers
- 101 people
- Sponsor
- UCB Pharma
Pulmonary Disease, Chronic Obstructive
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol…
- Trial name
- NCT00359788
- Testing
- tiotropium, Combivent (Ipratropium/Albuterol)
- Where
- 31 sites in United States
- Volunteers
- 349 people
- Sponsor
- Boehringer Ingelheim
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
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
Infections, Rotavirus
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
- Trial name
- NCT00938327
- Testing
- Rotarix™
- Where
- 12 sites in India
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.
- Trial name
- NCT02043808
- Where
- United States
- Volunteers
- 25,586 people
- Sponsor
- Boehringer Ingelheim
Erectile Dysfunction, Cardiovascular Diseases
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Erectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years.
- Conditions
- Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
- Trial name
- NCT01150903
- Testing
- no intervention
- Volunteers
- 98,832 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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
Influenza
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
- Trial name
- NCT01222403
- Testing
- Fluad_MF59-adjuvanted trivalent influenza subunit vaccine, Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
- Where
- 23 sites in South Korea
- Volunteers
- 767 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Idiopathic Pulmonary Fibrosis
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis.
- Trial name
- NCT03047031
- Testing
- Nintedanib, Pirfenidone
- Where
- 8 sites in India
- Volunteers
- 21 people
- Sponsor
- Boehringer Ingelheim
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least…
- Trial name
- NCT00750893
- Testing
- Rotarix or Rotarix liquid formulation
- Where
- South Korea
- Volunteers
- 3,111 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.
- Trial name
- NCT02061748
- Testing
- Observational
- Where
- United States
- Volunteers
- 38,499 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
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
Diffuse Large B-Cell Lymphoma
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell…
- Trial name
- NCT01144403
- Testing
- Cyclophosphamide, Fludarabine, Mitoxantrone
- Where
- 8 sites in Romania
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 2
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
- Trial name
- AVANDAMETPMS (NCT01294553)
- Testing
- Administration of rosiglitazone/metformin
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.
- Trial name
- ReAlise (NCT00234884)
- Testing
- adalimumab
- Where
- 311 sites in Australia, Austria and 9 more
- Volunteers
- 3,435 people
- Sponsor
- Abbott
Infection
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily…
- Trial name
- NCT00488488
- Testing
- tigecycline
- Volunteers
- 1,028 people
- Sponsor
- Pfizer