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Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

Primary Purpose

Duodenal Ulcer

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 Duodenal Ulcer focused on measuring Drug Therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
  2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

  1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
  2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
  3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
  4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
  5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
  6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
  7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
  8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAK-438 20 mg QD

Lansoprazole 30 mg QD

Arm Description

Outcomes

Primary Outcome Measures

Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

Secondary Outcome Measures

Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer

Full Information

First Posted
September 16, 2011
Last Updated
August 19, 2013
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01452724
Brief Title
Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
Official Title
A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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 duodenal ulcer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Ulcer
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
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAK-438 20 mg QD
Arm Type
Experimental
Arm Title
Lansoprazole 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 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 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 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
Primary Outcome Measure Information:
Title
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
Description
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
Time Frame
4 weeks
Title
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
Time Frame
2 weeks
Title
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1). Outpatient (including short inpatient for examination and others) Exclusion Criteria: Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1) Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1) Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1) Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1) Participants with a gastric ulcer on endoscopy at baseline (Visit 1) Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage) Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1) Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Manager
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Toyota-shi
State/Province
Aichi
Country
Japan
City
Kamagaya-shi
State/Province
Chiba
Country
Japan
City
Kisarazu-shi
State/Province
Chiba
Country
Japan
City
Fukui-shi
State/Province
Fukui
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
City
Kurume-shi
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Tagawa-shi
State/Province
Fukuoka
Country
Japan
City
Yanagawa-shi
State/Province
Fukuoka
Country
Japan
City
Yukuhashi-shi
State/Province
Fukuoka
Country
Japan
City
Sappori-shi
State/Province
Hokkaido
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan
City
Nishinomiya-shi
State/Province
Hyogo
Country
Japan
City
Takarazuka-shi
State/Province
Hyogo
Country
Japan
City
Hitachi-shi
State/Province
Ibaraki
Country
Japan
City
Hitacinaka-shi
State/Province
Ibaraki
Country
Japan
City
Marugame-shi
State/Province
Kagawa
Country
Japan
City
Takamatsu-shi
State/Province
Kagawa
Country
Japan
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
City
Kanoya-shi
State/Province
Kagoshima
Country
Japan
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Yashiro-shi
State/Province
Kumamoto
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
City
Sasebo-shi
State/Province
Nagasaki
Country
Japan
City
Oita-shi
State/Province
Oita
Country
Japan
City
Okayama-shi
State/Province
Okayama
Country
Japan
City
Shimajiri-gun
State/Province
Okinawa
Country
Japan
City
Daito-shi
State/Province
Osaka
Country
Japan
City
Fujiidera-shi
State/Province
Osaka
Country
Japan
City
Hirakata-shi
State/Province
Osaka
Country
Japan
City
Kishiwada-shi
State/Province
Osaka
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Sakai-shi
State/Province
Osaka
Country
Japan
City
Suita-shi
State/Province
Osaka
Country
Japan
City
Takatsuki-shi
State/Province
Osaka
Country
Japan
City
Toyonaka-shi
State/Province
Osaka
Country
Japan
City
Saga-shi
State/Province
Saga
Country
Japan
City
Ageo-shi
State/Province
Saitama
Country
Japan
City
Kumagaya-shi
State/Province
Saitama
Country
Japan
City
Tokorozawa-shi
State/Province
Saitama
Country
Japan
City
Otsu-shi
State/Province
Shiga
Country
Japan
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
City
Ashikaga-shi
State/Province
Tochigi
Country
Japan
City
Otawara-shi
State/Province
Tochigi
Country
Japan
City
Shimotsuga-gun
State/Province
Tochigi
Country
Japan
City
Shimotsuke-shi
State/Province
Tochigi
Country
Japan
City
Tokushima-shi
State/Province
Tokushima
Country
Japan
City
Hachioji-shi
State/Province
Tokyo
Country
Japan
City
Kodaira-shi
State/Province
Tokyo
Country
Japan
City
Kokubunji-shi
State/Province
Tokyo
Country
Japan
City
Meguro-ku
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Mitaka-shi
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
City
Wakayama-shi
State/Province
Wakayama
Country
Japan
City
Yamagata-shi
State/Province
Yamagata
Country
Japan
City
Shimonoseki-shi
State/Province
Yamaguchi
Country
Japan
City
Kofu-shi
State/Province
Yamanashi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27891632
Citation
Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

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