Clinical trials: Omeprazole
- Drug or intervention Omeprazole
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Gastroesophageal Reflux Disease (GERD)
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age…
- Trial name
- NCT00241501
- Testing
- Esomeprazole (Nexium)
- Where
- 40 sites in United States, Canada and 2 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Gastroesophageal Reflux Disease (GERD)
Phase 3/Safety & Efficacy of Esomeprazole in Infants
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
- Trial name
- NCT00468559
- Testing
- Open Label Run In Esomeprazole, Double Blind Esomeprazole
- Where
- 25 sites in United States, France and 2 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Gastroesophageal Reflux Disease (GERD), Erosive Esophagitis
Esomeprazole for Treatment of GERD in Pediatric Patients
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease…
- Conditions
- Gastroesophageal Reflux Disease (GERD), Erosive Esophagitis, Non-erosive Esophagitis
- Trial name
- NCT00228527
- Testing
- Esomeprazole (Nexium)
- Where
- 36 sites in United States, Belgium and 2 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Laryngopharyngeal Reflux, Throat Pain
Anti-reflux Control to Decrease Post Tonsillectomy Pain
The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain.
- Trial name
- NCT01777854
- Testing
- Omeprazole
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Ascension Health
Gastric Ulcer, Duodenal Ulcer
Nexium Capsules LDA Specific Clinical Experience Investigation
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose…
- Trial name
- NCT01729182
- Where
- 47 sites in Japan
- Volunteers
- 2,363 people
- Sponsor
- AstraZeneca
Pharmacokinetics
Phase 1 Pharmacokinetics of Intravenous Nexium in Children
The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require…
- Trial name
- NCT00474019
- Testing
- esomeprazole
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
Repeatedly Recurring Esophagitis, Relapsing Reflux Esophagitis
Nexium Capsules RE Maintenance Specific Clinical Experience Investigation
The purpose of this study is to collect following data in patients given Nexium capsule (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly recurring/relapsing reflux oesophagitis.
- Trial name
- NCT01562639
- Where
- 46 sites in Japan
- Volunteers
- 647 people
- Sponsor
- AstraZeneca
Erosive Esophagitis
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
- Trial name
- EE (NCT05267613)
- Testing
- Nexium 20mg, Nexium 10mg
- Where
- 41 sites in United States, Argentina and 8 more
- Volunteers
- 53 people
- Sponsor
- AstraZeneca
Peptic Ulcer, Gastroesophageal Reflux
S-CEI of Nexium in Paediatric Patients
To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch
- Trial name
- NCT03562026
- Where
- 31 sites in Japan
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Upper Gastrointestinal Bleeding
Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage.
- Trial name
- NCT00045799
- Testing
- Omeprazole sodium bicarbonate immediate release PWD/FS, Cimetidine IV
- Where
- 58 sites in United States
- Volunteers
- 354 people
- Sponsor
- Bausch Health Americas, Inc.
Gastric Ulcer, Duodenal Ulcer
Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with…
- Trial name
- NCT01562600
- Where
- 46 sites in Japan
- Volunteers
- 1,634 people
- Sponsor
- AstraZeneca
Homeostasis, Bone and Bones
Effect of Dexlansoprazole on Bone Homeostasis
The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.
- Trial name
- NCT01216293
- Testing
- Dexlansoprazole, Esomeprazole
- Where
- 12 sites in United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Takeda
Familial Hypercholesterolemia
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind…
- Trial name
- NCT00355615
- Testing
- Rosuvastatin
- Where
- 20 sites in United States, Canada and 3 more
- Volunteers
- 173 people
- Sponsor
- AstraZeneca
Juvenile Idiopathic Arthritis (JIA)
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
- Trial name
- NCT01544114
- Testing
- VIMOVO 250/20, VIMOVO 375/20, VIMOVO 500/20
- Where
- 17 sites in United States
- Volunteers
- 46 people
- Sponsor
- Amgen
Type 1 Diabetes
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Omeprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes…
- Trial name
- IIT (NCT01762644)
- Testing
- Oral Cyclosporine and Oral Omeprazole, Oral Omeprazole
- Sponsor
- Perle Bioscience, Inc.
Death, Sudden, Cardiac
An Observational Study to Assess the Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide
The purpose of this observational study is to assess the risk of out-of-hospital Sudden Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current use of a Proton Pump Inhibitor (PPI), current use…
- Trial name
- NCT01907633
- Testing
- No intervention
- Volunteers
- 15,000 people
- Sponsor
- Janssen Research & Development, LLC
Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,"Non-erosive Reflux Disease, Zollinger-Ellison Syndrome
Nexium Capsules Clinical Experience Investigation
The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed Nexium for "gastric ulcer", "duodenal…
- Trial name
- NCT01434485
- Where
- 47 sites in Japan
- Volunteers
- 3,691 people
- Sponsor
- AstraZeneca
Endoscopically-Proven GERD, Reflux
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive…
- Trial name
- NCT00687245
- Testing
- esomeprazole magnesium
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Gastric Ulcer, Duodenal Ulcer
Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation
The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium + amoxicillin (AMPC) + clarithromycin (CAM)…
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Gastric Mucosa-associated Lymphoid Tissue (MALT), Lymphoma Idiopathic Thrombocytopenic Purpura
- Trial name
- NCT01435525
- Where
- 36 sites in Japan
- Volunteers
- 369 people
- Sponsor
- AstraZeneca
Reflux Esophagitis
Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
- Trial name
- NCT02477475
- Where
- 47 sites in Japan
- Volunteers
- 1,595 people
- Sponsor
- AstraZeneca