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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01630746
First received: June 26, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Erosive Esophagitis
Drug: TAK-438
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Time-course of changes in 24-hour gastroesophageal pH [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.


Enrollment: 19
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-438 20 mg/day Drug: TAK-438
Experimental: TAK-438 40 mg/day Drug: TAK-438

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase.
  2. Outpatient (in principle)
  3. 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.
  4. The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).

Exclusion Criteria:

  1. 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.
  2. 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)
  3. 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.
  4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630746

Locations
Japan
Gifu-shi, Gifu, Japan
Sapporo-shi, Hokkaido, Japan
Hitachi-shi, Ibaraki, Japan
Kochi-shi, Kochi, Japan
Sendai-shi, Miyagi, Japan
Osaka-shi, Osaka, Japan
Saga-shi, Saga, Japan
Izumo-shi, Shimane, Japan
Hamamatsu-shi, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01630746     History of Changes
Other Study ID Numbers: TAK-438/OCT-002, JapicCTI-121882, U1111-1130-9074
Study First Received: June 26, 2012
Last Updated: February 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014