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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Duodenal Ulcer	Drug: TAK-438; Drug: Placebo; Drug: Lansoprazole	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	372 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	October 2011
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	February 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: TAK-438 20 mg QD	Drug: TAK-438; TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks. Drug: Placebo; Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
Active Comparator: Lansoprazole 30 mg QD	Drug: Lansoprazole; Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.; Other Name: AG-1749 Drug: Placebo; TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.

Outcome Measures

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Primary Outcome Measures :

1. Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks [ Time Frame: 6 weeks ]
   Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

Secondary Outcome Measures :

1. Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks [ Time Frame: 4 weeks ]
2. Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [ Time Frame: 2 weeks ]
3. Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer [ Time Frame: Baseline and 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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  Show 64 Study Locations

Sponsors and Collaborators

Takeda

Investigators

Study Director:	Senior Manager	Takeda

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT01452724 History of Changes
Other Study ID Numbers:	TAK-438/CCT-102; U1111-1123-8648 ( Registry Identifier: WHO ); JapicCTI-111608 ( Registry Identifier: JapicCTI )
First Posted:	October 17, 2011
Last Update Posted:	August 20, 2013
Last Verified:	August 2013

Keywords provided by Takeda:

Drug Therapy

Additional relevant MeSH terms:

Ulcer; Duodenal Ulcer; Pathologic Processes; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases	Stomach Diseases; Lansoprazole; Dexlansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action