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

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:

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda:

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 ]


Enrollment:	372
Study Start Date:	October 2011
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452724

Show 64 Study Locations

Sponsors and Collaborators

Takeda

Investigators


Study Director:	Senior Manager	Takeda

More Information


Responsible Party:	Takeda
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:	August 19, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 26, 2016