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Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

Primary Purpose

Erosive Esophagitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TAK-438
Placebo
Lansoprazole
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Esophagitis focused on measuring Drug Therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants.
  2. Outpatient (including inpatient for examination)

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) within 30 days prior to Visit 1 (start of the observation period). 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAK-438 20 mg QD

AG-1749 30 mg QD

Arm Description

Outcomes

Primary Outcome Measures

Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).

Secondary Outcome Measures

Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

Full Information

First Posted
September 16, 2011
Last Updated
November 7, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01452698
Brief Title
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis
Official Title
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAK-438 20 mg QD
Arm Type
Experimental
Arm Title
AG-1749 30 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TAK-438
Intervention Description
TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
AG-1749
Intervention Description
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
AG-1749
Intervention Description
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
Primary Outcome Measure Information:
Title
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Description
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis
Time Frame
2 Weeks
Title
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants. Outpatient (including inpatient for examination) 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) within 30 days prior to Visit 1 (start of the observation period). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Manager
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Nagoya-shi
State/Province
Aichi
Country
Japan
City
Abiko-shi
State/Province
Chiba
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Itoshima-shi
State/Province
Fukuoka
Country
Japan
City
Kurume-shi
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Gifu-shi
State/Province
Gifu
Country
Japan
City
Annaka-shi
State/Province
Gunma
Country
Japan
City
Aki-gun
State/Province
Hiroshima
Country
Japan
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan
City
Takarazuka-shi
State/Province
Hyogo
Country
Japan
City
Sakade-shi
State/Province
Kagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Kochi-shi
State/Province
Kochi
Country
Japan
City
Susaki-shi
State/Province
Kochi
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
City
Oita-shi
State/Province
Oita
Country
Japan
City
Okayama-shi
State/Province
Okayama
Country
Japan
City
Fuziidera-shi
State/Province
Osaka
Country
Japan
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
City
Otawara-shi
State/Province
Tochigi
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Nakano-ku
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Yamagata-shi
State/Province
Yamagata
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

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