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Completed

NCT Number: NCT01456247

Long-term Extension Study 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 safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy 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 completed the preceding study
  • Outpatient (including inpatient for examinations)

Exclusion criteria

  • 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
  • Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
  • Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
  • 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 28-80 weeks.

Placebo

Drug

Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.

Lansoprazole

Drug

Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.

Other names: AG-1749

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: Up to 80 weeks.

    Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.

Secondary outcomes

  1. Change from baseline in Laboratory values

    Time frame: Up to 80 weeks.

  2. Change from baseline in Electrocardiograms

    Time frame: Up to 80 weeks.

  3. Change from baseline in Vital signs

    Time frame: Up to 80 weeks.

  4. Change from baseline in Serum gastrin

    Time frame: Up to 80 weeks.

  5. Change from baseline in Pepsinogen I and II

    Time frame: Up to 80 weeks.

  6. Recurrence rate of gastric or duodenal ulcer

    Time frame: Up to 80 weeks.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy 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
2012
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2011
Registry last updated
May 8, 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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