Clinical trials: Reflux
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
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
- Trial name
- NCT00300755
- Testing
- pantoprazole sodium enteric-coated spheroid
- Where
- 43 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Erosive Esophagitis, Heartburn
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are…
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection
- Trial name
- NCT06660342
- Testing
- Vonoprazan
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Phathom Pharmaceuticals, Inc.
Gastroesophageal Reflux Disease (GERD)
A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach.
- Trial name
- NCT02616302
- Testing
- Dexlansoprazole
- Where
- 18 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Takeda
Gastroesophageal Reflux in Children
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
- Trial name
- STELLAR (NCT04358146)
- Testing
- Experimental Infant formula, Infant formula thickened with locust bean gum
- Where
- 12 sites in Belgium, France and 2 more
- Volunteers
- 346 people
- Sponsor
- United Pharmaceuticals
Cough, Asthma
Validation of the C-mo System - Cough Monitoring
The goal of this clinical study is to validate C-mo System's ability to automatically detect and characterise cough, in patients over 2 years old with cough as a key or refractory symptom.
- Conditions
- Cough, Asthma, Chronic Obstructive Pulmonary Disease, Gastro Esophageal Reflux
- Trial name
- C-mo_01 (NCT05989698)
- Testing
- C-mo System
- Where
- 8 sites in Portugal
- Volunteers
- 300 people
- Sponsor
- Cough Monitoring Medical Solutions
Reflux Esophagitis, Gastric Ulcer
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and…
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Trial name
- NCT03553563
- Testing
- D961H capsule 10mg, D961H sachet 10mg
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Reflux Esophagitis
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.
- Trial name
- NCT03214081
- Testing
- Vonoprazan
- Where
- Japan
- Volunteers
- 1,237 people
- Sponsor
- Takeda
Gastroesophageal Reflux
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
- Trial name
- NCT05343364
- Testing
- Vonoprazan
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- Phathom Pharmaceuticals, Inc.
Functional Gastrointestinal Disorders
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an…
- Trial name
- NCT06488274
- Testing
- New infant formula
- Where
- 4 sites in France
- Volunteers
- 139 people
- Sponsor
- United Pharmaceuticals
Stool Assessment, Skin Rash
GI Symptoms in Infants Fed Goat Milk-based Infant Formula
A cross-sectional observational survey was conducted in Brazil, Mexico, Russia, and The Netherlands by recruiting parents/legal guardians through social media.
- Conditions
- Stool Assessment, Skin Rash, Urticaria, Regurgitation
- Trial name
- NCT06755424
- Where
- Netherlands
- Volunteers
- 425 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Gastroesophageal Reflux Disease
A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease
The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily [QD]) in children ≥ 6 to < 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
- Trial name
- NCT06106022
- Testing
- Vonoprazan
- Where
- 13 sites in United States
- Volunteers
- 22 people
- Sponsor
- Phathom Pharmaceuticals, Inc.
Gastrointestinal Disorder, Functional, Regurgitation, Gastric
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from…
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional
- Trial name
- TIGER (NCT05363553)
- Testing
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Where
- Thailand
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Gastroesophageal Reflux Disease
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
- Trial name
- NCT02401035
- Testing
- IV pantoprazole
- Where
- 19 sites in United States, Argentina and 7 more
- Volunteers
- 19 people
- Sponsor
- Pfizer
Regurgitation, Gastric, Diarrhea
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
- Trial name
- Solar (NCT04042454)
- Testing
- milk based anti-regurgitation infant formula, Milk based infant formula
- Where
- 16 sites in Italy, Poland and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Infantile Colic, Constipation
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food…
- Conditions
- Infantile Colic, Constipation, Infantile Diarrhea, Gastro Esophageal Reflux
- Trial name
- NCT04262648
- Testing
- Lactobacillus Reuteri
- Where
- 2 sites in Russia
- Volunteers
- 90 people
- Sponsor
- NovoNatum Ltd
Infant Nutrition Disorders, Gastrointestinal Dysfunction
Management of Infant Digestive Disorders and Quality of Life
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
- Trial name
- NCT04462640
- Testing
- Management of Infant Digestive Disorders and Quality of Life
- Where
- France
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Regurgitation, Gastric
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
- Trial name
- Leopard (NCT03371615)
- Testing
- Anti-regurgitation infant formula
- Where
- 2 sites in Poland
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
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