Clinical trials: Oesophagitis
Refractory Reflux Esophagitis
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of…
- Trial name
- NCT01669811
- Testing
- Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
- Where
- 63 sites in Japan
- Volunteers
- 1,398 people
- Sponsor
- AstraZeneca
Erosive Esophagitis
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
- Trial name
- NCT01452698
- Testing
- TAK-438, Lansoprazole
- Where
- 32 sites in Japan
- Volunteers
- 409 people
- Sponsor
- Takeda
Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
- Conditions
- Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome
- Trial name
- EAGLE (NCT02953223)
- Testing
- Free amino acid infant formula
- Where
- 29 sites in United States
- Volunteers
- 144 people
- Sponsor
- Société des Produits Nestlé (SPN)
Esophagitis
Risk of Cancer Among Pantoprazole Users
The primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.
- Trial name
- NCT01322633
- Testing
- Does not apply
- Volunteers
- 61,864 people
- Sponsor
- Pfizer
Eosinophilic Esophagitis
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult…
- Trial name
- CROSSING (NCT05583227)
- Testing
- Tezepelumab
- Where
- 124 sites in United States, Australia and 20 more
- Volunteers
- 368 people
- Sponsor
- AstraZeneca
Candidiasis, Esophageal, HIV Infections
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
- Trial name
- NCT00002339
- Testing
- Fluconazole
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Pfizer
Eosinophilic Oesophagitis
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5…
- Trial name
- NCT06101095
- Testing
- Dupilumab
- Where
- 30 sites in United States, Brazil and 3 more
- Volunteers
- 69 people
- Sponsor
- Sanofi
Esophagitis, Pneumonitis
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small…
- Conditions
- Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
- Trial name
- NCT00081315
- Testing
- Amifostine
- Where
- 24 sites in United States
- Volunteers
- 130 people
- Sponsor
- MedImmune LLC
Esophagitis, Gastroesophageal Reflux
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available.
- Conditions
- Esophagitis, Gastroesophageal Reflux, Stomach Ulcer, Duodenal Ulcer
- Trial name
- NCT00284908
- Testing
- S-Tenatoprazole-Na (STU-Na)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- STEBA France
Gastric Ulcer (GU), Duodenal Ulcer (DU)
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old…
- Conditions
- Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU), Non-erosive Reflux Esophagitis Disease (NERD)
- Trial name
- NCT02153398
- Testing
- D961H sachet 10 mg, D961H capsule 10mg, D961H capsule 20 mg
- Where
- 15 sites in Japan
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Eosinophilic Gastritis, Eosinophilic Duodenitis
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic…
- Trial name
- ENIGMA 2 (NCT04322604)
- Testing
- lirentelimab (AK002)
- Where
- 60 sites in United States
- Volunteers
- 181 people
- Sponsor
- Allakos Inc.
Reflux Esophagitis
Reflux Esophagitis Phase III Study (Initial Treatment)
This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by…
- Trial name
- NCT00633932
- Testing
- Esomeprazole, Omeprazole
- Where
- 41 sites in Japan
- Volunteers
- 602 people
- Sponsor
- AstraZeneca
GERD With Erosive Esophagitis
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.
The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg). The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate…
- Trial name
- NCT00206245
- Testing
- AZD0865
- Where
- 202 sites in United States, Canada and 8 more
- Volunteers
- 1,400 people
- Sponsor
- AstraZeneca
Radiation-induced Oesophagitis
Tepilta® Versus Oxetacaine, Antacids and Placebo
This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups.
- Trial name
- NCT01336530
- Testing
- oxetacaine, aluminium and magnesium hydroxide, oxetacaine, magnesium and aluminium hydroxide
- Where
- 32 sites in Austria, Germany
- Volunteers
- 40 people
- Sponsor
- MEDA Pharma GmbH & Co. KG
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
Erosive Esophagitis, GERD
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.
- Trial name
- NCT01509261
- Testing
- Ilaprazole, Lansoprazole
- Where
- 19 sites in South Korea
- Volunteers
- 292 people
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Eosinophilic Esophagitis
Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
- Trial name
- NCT04835168
- Testing
- BT-11 low, BT-11 high
- Sponsor
- NImmune Biopharma
Eosinophilic Esophagitis
A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany
This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with…
- Trial name
- ProMEAL (NCT06695897)
- Testing
- Dupilumab
- Where
- 15 sites in Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi
Eosinophilic Esophagitis
Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
This is a 2-part randomized, double-blind, placebo-controlled study followed by an open-label extension (OLE) of APT-1011 in adults with EoE.
- Trial name
- FLUTE-2 (NCT04281108)
- Testing
- APT-1011, Esophagogastroduodenoscopy
- Where
- 56 sites in United States, Australia and 1 more
- Volunteers
- 143 people
- Sponsor
- Ellodi Pharmaceuticals, LP
Erosive Esophagitis
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.
- Trial name
- NCT04124926
- Testing
- Vonoprazan, Lansoprazole
- Where
- 157 sites in United States, Bulgaria and 4 more
- Volunteers
- 1,027 people
- Sponsor
- Phathom Pharmaceuticals, Inc.