Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01452750
First received: September 16, 2011
Last updated: February 4, 2014
Last verified: February 2014

September 16, 2011
February 4, 2014
October 2011
June 2013   (final data collection date for primary outcome measure)
Recurrence rate of gastric or duodenal ulcer within 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.
Same as current
Complete list of historical versions of study NCT01452750 on ClinicalTrials.gov Archive Site
  • Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Gastric mucosal injury [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Duodenal mucosal injury [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
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).

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Gastric Ulcers
  • Duodenal Ulcers
  • Drug: TAK-438
    TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
  • Drug: Placebo
    Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
  • Drug: TAK-438
    TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
  • Drug: Lansoprazole
    Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
    Other Name: AG-1749
  • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
  • Experimental: TAK-438 10 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Experimental: TAK-438 20 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Active Comparator: Lansoprazole 15 mg QD
    Interventions:
    • Drug: Lansoprazole
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
642
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01452750
TAK-438/CCT-301, U1111-1123-8722, JapicCTI-111613
No
Takeda
Takeda
Not Provided
Study Director: Senior Manager Takeda
Takeda
February 2014

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