Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
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ClinicalTrials.gov Identifier: NCT01452724 |
Recruitment Status
:
Completed
First Posted
: October 17, 2011
Last Update Posted
: August 20, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Duodenal Ulcer | Drug: TAK-438 Drug: Placebo Drug: Lansoprazole | Phase 3 |
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 |
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.
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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.
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- 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.
- Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks [ Time Frame: 4 weeks ]
- Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [ Time Frame: 2 weeks ]
- Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer [ Time Frame: Baseline and 6 weeks ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452724

Study Director: | Senior Manager | Takeda |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |