NCT Number: NCT01630746
A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis
The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Gifu, Japan
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase.
- Outpatient (in principle)
- At the endoscopy scheduled for the Observation Phase (Visit 2), the participant must have endoscopically confirmed reflux esophagitis of Grade A to D, as defined by the LA classification grading system, which remains insufficiently controlled with standard-dose or higher-than-standard-dose PPI therapy.
- The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).
Exclusion criteria
- Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
- Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) at the start of the Observation Phase (Visit 1) or at endoscopy during the Observation Phase (Visit 2) . However, participants with gastric or duodenal erosions are allowed to be included.
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.
Treatment and study plan
Primary outcomes
-
Time-course of changes in 24-hour gastroesophageal pH
Time frame: Week 8
Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.
Sponsors and collaborators
Lead sponsor
Takeda
Industry
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jun 28, 2012
- Registry last updated
- Feb 10, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
NCT05055128
Erosive Esophagitis
Tampa, Florida, United States
View Trial DetailsA Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
NCT05587309
Erosive Esophagitis
Homewood, Alabama, United States
View Trial DetailsA Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
NCT05890001
Deglutition Disorders, Digestive System Diseases
Huntsville, Alabama, United States
View Trial DetailsA Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
NCT06391177
Erosive Esophagitis, Heartburn
Las Vegas, Nevada, United States
View Trial Details