Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
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| ClinicalTrials.gov Identifier: NCT01452763 |
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Recruitment Status :
Completed
First Posted : October 17, 2011
Last Update Posted : January 20, 2014
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Brief Summary:
The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Ulcers Duodenal Ulcers | Drug: TAK-438 Drug: Placebo Drug: Lansoprazole | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 621 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Low-dose Aspirin |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: TAK-438 10 mg QD |
Drug: TAK-438
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks. Drug: Placebo Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks. |
| Experimental: TAK-438 20 mg QD |
Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks. Drug: Placebo Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks. |
| Active Comparator: Lansoprazole 15 mg QD |
Drug: Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Other Name: AG-1749 Drug: Placebo TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks. |
Primary Outcome Measures :
- Recurrence rate of gastric or duodenal ulcer within 24 weeks [ Time Frame: 24 weeks ]Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.
Secondary Outcome Measures :
- Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ]
- Gastric mucosal injury [ Time Frame: 24 Weeks ]
- Duodenal mucosal injury [ Time Frame: 24 weeks ]
- Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ]
- Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ]
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
- Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
- Outpatient (including inpatient for examinations)
Exclusion Criteria:
- Participants scheduled to change the type and dosage regimen of low-dose aspirin
- Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
- Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
- Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a previous or current history of aspirin-induced asthma
Information from the National Library of Medicine
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): NCT01452763
Locations
Show 76 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Senior Manager | Takeda |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT01452763 |
| Other Study ID Numbers: |
TAK-438/CCT-302 U1111-1123-8746 ( Registry Identifier: WHO (UTN) ) JapicCTI-111610 ( Registry Identifier: JapicCTI ) |
| First Posted: | October 17, 2011 Key Record Dates |
| Last Update Posted: | January 20, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Takeda:
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Drug Therapy |
Additional relevant MeSH terms:
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Stomach Ulcer Duodenal Ulcer 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 |