Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

Takeda

Status and phase: Completed; Phase 3

Conditions: Duodenal Ulcers; Gastric Ulcers

Treatments: Drug: TAK-438; Drug: Placebo; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01456260

U1111-1123-8762 (Registry Identifier)

JapicCTI-111611 (Registry Identifier)

TAK-438/OCT-301

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

Enrollment: 406 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants who require continuous NSAID therapy during the treatment period with the study drug
2. Participants who have completed the preceding study
3. Outpatient (including inpatient for examinations)

Exclusion criteria

1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
2. Participants who are scheduled to change the type and dosage regimen of NSAID
3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
5. 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
6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
7. Participants with a previous or current history of aspirin-induced asthma

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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406 participants in 3 patient groups

TAK-438 10 mg QD

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: TAK-438

Drug: TAK-438

Drug: Placebo

TAK-438 20 mg QD

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: TAK-438

Drug: TAK-438

Drug: Placebo

Lansoprazole 15 mg QD

Active Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Lansoprazole

Drug: Placebo