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Completed

NCT Number: NCT01452711

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.

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Key information

Conditions

Gastric Ulcer Digestive System Diseases Duodenal Diseases 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

Toyota-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 must have endoscopically confirmed gastric 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 Gastric Mucosal Lesion (AGML) 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 duodenal 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)

Treatment and study plan

TAK-438

Drug

TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

Placebo

Drug

Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.

Lansoprazole

Drug

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Other names: AG-1749

Primary outcomes

  1. Endoscopic Healing Rate of Gastric Ulcer Over 8 weeks

    Time frame: 8 weeks

    Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

Secondary outcomes

  1. Endoscopic healing Rates of Gastric Ulcer on Endoscopy over 4 weeks

    Time frame: 4 weeks

  2. Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2

    Time frame: 2 weeks

  3. Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Gastric Ulcer

    Time frame: Baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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 Gastric Ulcer.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2011
Registry last updated
Jun 21, 2013

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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