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 is currently recruiting participants.
Verified January 2013 by Takeda Global Research & Development Center, Inc.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01630746
First received: June 26, 2012
Last updated: January 17, 2013
Last verified: January 2013
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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 Global Research & Development Center, Inc.:
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.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| 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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630746
Contacts
| Contact: Takeda Study Registration Call Center | +1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Japan | |
| Not yet recruiting | |
| Gifu-shi, Gifu, Japan | |
| Not yet recruiting | |
| Sapporo-shi, Hokkaido, Japan | |
| Not yet recruiting | |
| Hitachi-shi, Ibaraki, Japan | |
| Recruiting | |
| Kochi-shi, Kochi, Japan | |
| Not yet recruiting | |
| Sendai-shi, Miyagi, Japan | |
| Recruiting | |
| Osaka-shi, Osaka, Japan | |
| Not yet recruiting | |
| Saga-shi, Saga, Japan | |
| Not yet recruiting | |
| Izumo-shi, Shimane, Japan | |
| Recruiting | |
| Hamamatsu-shi, Shizuoka, Japan | |
| Recruiting | |
| Bunkyo-ku, Tokyo, Japan | |
| Not yet recruiting | |
| Mitaka-shi, Tokyo, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| Study Director: | Medical Director | Takeda Pharmaceutical Company Limited |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited ) |
| 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: | January 17, 2013 |
| 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 May 16, 2013