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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01452724 |
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Date of registration:
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16/09/2011 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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390 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01452724 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Takeda Study Registration Call Center |
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Address:
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Telephone:
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800-778-2860 |
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Email:
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medicalinformation@tpna.com |
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Affiliation:
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Name:
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Senior Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda Pharmaceutical Company Limited |
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Key inclusion & exclusion criteria
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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)
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Duodenal Ulcer
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Intervention(s)
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Drug: Lansoprazole
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Drug: Placebo
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Drug: TAK-438
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Primary Outcome(s)
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Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
[Time Frame: Baseline and 6 weeks]
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Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
[Time Frame: 2 weeks]
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Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
[Time Frame: 4 weeks]
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Secondary ID(s)
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JapicCTI-111608
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TAK-438/CCT-102
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U1111-1123-8648
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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