Long-term Extension Study 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:
NCT01456260
First received: September 16, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.


Condition Intervention Phase
Gastric Ulcers
Duodenal Ulcers
Drug: TAK-438
Drug: Placebo
Drug: Lansoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy 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)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.


Secondary Outcome Measures:
  • Change from baseline in Laboratory values [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Electrocardiograms [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Vital signs [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Serum gastrin [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Pepsinogen I and II [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Recurrence rate of gastric or duodenal ulcer [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: No ]

Enrollment: 406
Study Start Date: September 2011
Study Completion Date: December 2013
Arms Assigned Interventions
Experimental: TAK-438 10 mg QD Drug: TAK-438
TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
Drug: Placebo
Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.
Experimental: TAK-438 20 mg QD Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Active Comparator: Lansoprazole 15 mg QD Drug: Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
Other Name: AG-1749
Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants who require continuous NSAID therapy during the treatment period with the study drug
  2. Participants who have completed the preceding study
  3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

  1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
  2. Participants who are scheduled to change the type and dosage regimen of NSAID
  3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
  4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
  5. 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
  6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  7. Participants with a previous or current history of aspirin-induced asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456260

  Show 97 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01456260     History of Changes
Other Study ID Numbers: TAK-438/OCT-301, U1111-1123-8762, JapicCTI-111611
Study First Received: September 16, 2011
Last Updated: May 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Duodenal Ulcer
Stomach Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Lansoprazole
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014