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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: |
NCT01452750 |
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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 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
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Scientific title:
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A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety 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 Non-steroidal Anti-inflammatory Drug (NSAID). |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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630 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01452750 |
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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: Prevention
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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 who require continuous NSAID therapy during the treatment period with
the study drug
2. Participants who have a history of ulcer in stomach or duodenum, endoscopically
confirmed
3. Outpatient (including inpatient for examinations)
Exclusion Criteria:
1. Participants scheduled to change the type and dosage regimen of NSAID
2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
3. Participants with small intestine bleeding, large intestine bleeding, or
gastrointestinal bleeding of unknown etiology
4. 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
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or
other gastric acid hypersecretion disorders
6. Participants with a previous or current history of aspirin-induced asthma
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 Ulcers
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Gastric Ulcers
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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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Recurrence rate of gastric or duodenal ulcer within 24 weeks
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Duodenal mucosal injury
[Time Frame: 24 weeks]
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Gastric mucosal injury
[Time Frame: 24 Weeks]
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Occurrence rate of hemorrhagic lesion in stomach or duodenum
[Time Frame: 24 weeks]
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Recurrence rate of gastric or duodenal ulcer within 12 weeks
[Time Frame: 12 weeks]
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Time to recurrence of gastric or duodenal ulcer
[Time Frame: 24 weeks]
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Secondary ID(s)
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JapicCTI-111613
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TAK-438/CCT-301
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U1111-1123-8722
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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