Clinical Trial: Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 P

Brief Summary: The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.

Detailed Summary:
Sponsor: Takeda

Current Primary Outcome: Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks [ Time Frame: 6 weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks [ Time Frame: 4 weeks ]
  • Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [ Time Frame: 2 weeks ]
  • Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer [ Time Frame: Baseline and 6 weeks ]


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: September 16, 2011
Date Started: October 2011
Date Completion:
Last Updated: August 19, 2013
Last Verified: August 2013