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

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ClinicalTrials.gov Identifier: NCT01452724
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

September 16, 2011
October 17, 2011
August 20, 2013
October 2011
February 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01452724 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
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 Duodenal Ulcer
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Duodenal Ulcer
  • Drug: TAK-438
    TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
  • Drug: Placebo
    Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
  • Drug: Lansoprazole
    Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
    Other Name: AG-1749
  • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
  • Experimental: TAK-438 20 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Active Comparator: Lansoprazole 30 mg QD
    Interventions:
    • Drug: Lansoprazole
    • Drug: Placebo
Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
372
390
February 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participants must have endoscopically confirmed duodenal 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).
  2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

  1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
  2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
  3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
  4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
  5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
  6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
  7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
  8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01452724
TAK-438/CCT-102
U1111-1123-8648 ( Registry Identifier: WHO )
JapicCTI-111608 ( Registry Identifier: JapicCTI )
No
Not Provided
Not Provided
Takeda
Takeda
Not Provided
Study Director: Senior Manager Takeda
Takeda
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP