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Completed

NCT Number: NCT01452763

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

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.

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Key information

Conditions

Gastric Ulcers Digestive System Diseases Duodenal Diseases Duodenal Ulcer Duodenal Ulcers Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Komaki-shi, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAK-438

Drug

TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.

Placebo

Drug

Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

Lansoprazole

Drug

Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.

Other names: AG-1749

Primary outcomes

  1. 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 outcomes

  1. Recurrence rate of gastric or duodenal ulcer within 12 weeks

    Time frame: 12 weeks

  2. Gastric mucosal injury

    Time frame: 24 Weeks

  3. Duodenal mucosal injury

    Time frame: 24 weeks

  4. Occurrence rate of hemorrhagic lesion in stomach or duodenum

    Time frame: 24 weeks

  5. Time to recurrence of gastric or duodenal ulcer

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2011
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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