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

This study is currently recruiting participants.
Verified July 2012 by Takeda Global Research & Development Center, Inc.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01452724
First received: September 16, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Duodenal Ulcer
 Drug: TAK-438
Drug: Placebo
Drug: Lansoprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452724

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

  Show 64 Study Locations
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
Study Director: Senior Manager Takeda Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT01452724     History of Changes
Other Study ID Numbers: TAK-438/CCT-102, U1111-1123-8648, JapicCTI-111608
Study First Received: September 16, 2011
Last Updated: July 25, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda Global Research & Development Center, Inc.:
Drug Therapy

Additional relevant MeSH terms:
Duodenal Diseases
Duodenal Ulcer
Ulcer
Peptic Ulcer
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
 Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013