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OpenTrials
Completed

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gifu, Japan

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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

TAK-438

Drug

Primary outcomes

  1. 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.

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